US Market News
1週前
Rigel Appoints Board Member Alison L. Hannah, M.D. as Chief Medical OfficerJuly 1, 2026 8:05 AM
PR Newswire (US) Dr. Hannah has decades of oncology drug development experience and has served on Rigel's Board of Directors since 2021 She has resigned from Rigel's Board of Directors to join the companySOUTH SAN FRANCISCO, Calif., July 1, 2026 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced the appointment of Alison L. Hannah, M.D. to the role of Executive Vice President and Chief Medical Officer. Dr. Hannah has resigned from Rigel's Board of Directors, effective July 1, 2026, in connection with her appointment. She succeeds Lisa Rojkjaer, M.D., as Chief Medical Officer."Alison has been a valued member of Rigel's Board, and we are pleased to welcome her to the executive leadership team as Chief Medical Officer at an exciting time for Rigel. Her deep experience leading oncology clinical development and advancing investigational therapies through the regulatory process will be extremely valuable as we continue to advance our development pipeline, including R289 in lower-risk MDS, vepdegestrant in metastatic breast cancer and other potential opportunities," said Raul Rodriguez, Rigel's president and CEO. "On behalf of the entire Rigel team, I want to sincerely thank Lisa for her dedication and many contributions to the company."Rigel's leading pipeline asset, R2891, a potent and selective dual inhibitor of interleukin receptor-associated kinases 1 and 4 (IRAK1/4), continues to be advanced in its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with relapsed or refractory lower-risk myelodysplastic syndrome (MDS). Enrollment in the dose expansion phase of the study is ongoing, and Rigel remains on track to complete enrollment and select the recommended Phase 2 dose for future clinical studies in the second half of 2026. The company continues to anticipate sharing preliminary data from the dose expansion phase of the study by the end of 2026. In addition, Rigel is progressing its evaluation of other potential indications to advance R289 and is planning to provide an update later this year."I am excited to join Rigel at this important stage in the company's evolution. Having served on Rigel's Board, I have seen firsthand the strength of the team, the scientific rationale behind its programs and the opportunity to advance meaningful new therapies for patients with hematologic disorders and cancer," said Dr. Hannah. "I look forward to working closely with the leadership team to help guide the continued development of R289 and Rigel's broader clinical strategy, including the recent addition of vepdegestrant."About Dr. Hannah
Alison L. Hannah, M. D. has been appointed Executive Vice President and Chief Medical Officer (CMO) of Rigel. She resigned from Rigel's Board of Directors, which she had served on since May 2021, in connection with her appointment as CMO. Previously, Dr. Hannah has held the roles of Chief Medical Officer of CytomX Therapeutics, where she oversaw clinical development of conditionally activated protein therapeutics, and Senior Medical Director at SUGEN, Inc. (acquired by Pharmacia & Upjohn, now Pfizer), where she had oversight of clinical development, clinical operations, and pharmacovigilance, specializing in the development of tyrosine kinase inhibitors, including sunitinib (SUTENT) approved for the treatment of kidney cancer and imatinib-refractory gastrointestinal stromal tumors. Dr. Hannah has served as a consultant to the pharmaceutical and biotechnology industry since 2000, directing the development of investigational cancer therapies. In this capacity, Dr. Hannah has successfully filed over 40 regulatory applications for first-in-human clinical testing and has played significant roles in the broad marketing approval of multiple anticancer therapeutics. Dr. Hannah began her career at Quintiles, a global contract research organization, where she specialized in overseeing early to registrational-stage oncology clinical trials. She has served since June 2015 on the Board of Directors for Neogenomics, a cancer diagnostic firm. Dr. Hannah received her B.A. in biochemistry and immunology from Harvard University and her M.D. from the University of St Andrews.About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit www.rigel.com.R289 is an investigational compound not approved by the FDA.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 relating to, among other things, Rigel's clinical development plans and the potential of its product candidates, including R289; the anticipated timing of enrollment completion, dose selection and preliminary data from the ongoing Phase 1b clinical study of R289 in patients with relapsed or refractory lower-risk myelodysplastic syndrome (MDS); the evaluation of additional potential indications for R289; the advancement of Rigel's broader development pipeline, including vepdegestrant; and the expected contributions of Dr. Alison L. Hannah as Rigel's Chief Medical Officer. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "anticipates," "believes," "expects," "intends," "may," "plans," "potential," "will," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on Rigel's current beliefs, expectations and assumptions and involve risks and uncertainties that are difficult to predict and, in many cases, are beyond Rigel's control. Actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including, without limitation, risks associated with the timing, progress and results of Rigel's clinical trials; the ability to successfully develop and obtain regulatory approval for product candidates; the availability of funding for development activities; the occurrence of unforeseen safety or efficacy findings; the ability to enroll patients in clinical trials; competition from other therapies; reliance on third parties for clinical development, manufacturing and other services; changes in applicable laws or regulations; and other risks described from time to time in Rigel's filings with the Securities and Exchange Commission, including the "Risk Factors" section of Rigel's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement in this press release speaks only as of the date on which it is made. Rigel undertakes no obligation to update or revise any forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.Contact for Investors & Media:Investors:
Rigel Pharmaceuticals, Inc.
650.624.1232
ir@rigel.com Media:
David Rosen
Argot Partners
646.461.6387
david.rosen@argotpartners.com View original content to download multimedia:https://www.prnewswire.com/news-releases/rigel-appoints-board-member-alison-l-hannah-md-as-chief-medical-officer-302815365.htmlSOURCE Rigel Pharmaceuticals, Inc. Original: Rigel Appoints Board Member Alison L. Hannah, M.D. as Chief Medical Officer
US Market News
2月前
Rigel Announces Oral and Poster Presentations at the 2026 ASCO Annual Meeting and EHA2026 CongressMay 21, 2026 5:17 PM
PR Newswire (US) Oral presentation at ASCO Annual Meeting to feature final data from the Phase 3 AcceleRET-Lung clinical trial of GAVRETO® (pralsetinib) as first-line treatment in patients with RET fusion-positive NSCLCFinal analysis from the Phase 1/2 ARROW clinical trial of pralsetinib in patients with advanced or metastatic RET-altered thyroid cancer to be presented in a poster sessionReal-world data further supports the use of REZLIDHIA® (olutasidenib) in patients with R/R mIDH1 AML that have received prior venetoclaxSOUTH SAN FRANCISCO, Calif., May 21, 2026 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced the final data from the Phase 3 AcceleRET-Lung clinical trial of GAVRETO® (pralsetinib) as first-line treatment of rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) will be presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on Friday, May 29, 2026.In addition, the ASCO Annual Meeting and European Hematology Association (EHA) 2026 Congress will feature poster presentations that include additional data for pralsetinib and data for REZLIDHIA® (olutasidenib) for the treatment of relapsed or refractory (R/R) isocitrate dehydrogenase-1 (mIDH1)-mutated acute myeloid leukemia (AML). The ASCO Annual Meeting is being held in Chicago, Illinois and virtually from May 29 to June 2, 2026 and the EHA2026 Congress is being held in Stockholm, Sweden and virtually from June 11 to June 14, 2026."Having an oral presentation at ASCO as well as multiple additional data presentations at both upcoming medical conferences underscores the continued clinical relevance of our oncology portfolio. We're pleased that data from the AcceleRET-Lung clinical study will be presented for the first time and the real-world outcome data for olutasidenib will be presented for patients with relapsed/refractory mIDH1 AML previously treated with venetoclax, further validating its role as a treatment option for these patients," said Raul Rodriguez, Rigel's president and CEO. "Together, these data reinforce our ability to deliver targeted therapies that significantly improve the lives of patients with difficult-to-treat cancers. We look forward to sharing these data with the medical community."Key highlights from the presentations at ASCO and EHA include:In the Phase 3 AcceleRET clinical trial, pralsetinib met the primary progression-free survival (PFS) endpoint and had a significantly greater overall response rate and more durable response vs. standard of care, demonstrating the clinical utility of pralsetinib in RET fusion-positive NSCLC. In terms of safety, there were 32 (30.0%) and 26 (25.0%) deaths in the pralsetinib and standard of care groups, respectively, with 8 (7.4%) and 0 due to infection. Increased monitoring suggests severe infection risk can be effectively managed.In the Phase 1/2 ARROW clinical study of pralsetinib in patients with RET altered thyroid cancer and medullary thyroid cancer, pralsetinib yielded clinically meaningful and durable responses with a manageable safety profile, consistent with prior reports.In an analysis of the patient, disease and molecular characteristics of long-term (LT) complete remission (CR)/CR with partial hematologic recovery (CRh) (>12 months duration of response) in the registrational Phase 2 clinical trial evaluating olutasidenib in patients with R/R mIDH1 AML, olutasidenib enabled LT CR/CRh in half of patients with CR/CRh without transplant (longest response >54 months). Estimated 48-month overall survival was 74% (95% CI: 51%, 88%). In a separate real-world assessment evaluating treatment patterns, safety and effectiveness of adults with R/R mIDH1 AML receiving olutasidenib following a venetoclax-based therapy in routine practice (73% of patients received olutasidenib as second-line therapy), a subgroup of patients that historically has very poor outcomes, 51 charts were collected from 18 physicians. Olutasidenib demonstrated robust real-world effectiveness with a CR/CRh rate of 60.8% and CR rate of 57% and a median response duration of 30.3 months. Substantial reductions in transfusion dependence further support olutasidenib as a viable post-venetoclax therapeutic option. These findings suggest that earlier sequencing of olutasidenib in the treatment paradigm may optimize patient outcomes.ASCO Annual Meeting abstracts may be accessed online via https://www.asco.org/abstracts. EHA2026 Congress abstracts may be accessed online via the EHA Library.ASCO Presentations Abstract TitleLead Author / PresenterPresentation Type / Abstract #Session TitleSession Date / Time (CT)GAVRETO (pralsetinib)Efficacy and safety of pralsetinib as first-line treatment of RET fusion-positive advanced or metastatic non-small cell lung cancer (NSCLC): The phase 3 AcceleRET-Lung studySanjay Popat, MBBS, FRCP, PhDOral presentation #8504Lung Cancer—Non-Small Cell MetastaticFriday, May 29, 2026 1:00pm – 4:00pm Efficacy and safety of pralsetinib in advanced or metastatic RET-altered thyroid cancer (TC): Final analysis of the phase 1/2 ARROW studyVivek Subbiah, MDPoster presentation #6028Head and Neck CancerSaturday, May 30, 20261:30pm – 4:30pmEfficacy and Safety of Pralsetinib in RET Fusion-Positive Solid Tumors: Data From the TAPISTRY Trial Chia-Chi Lin, MD, PhDPoster presentation #3144Developmental Therapeutics—Molecularly Targeted Agents and Tumor BiologySaturday, May 30, 20261:30pm – 4:30pmClinical factors driving use of RET inhibitor pralsetinib and associated real-world outcomes in RET fusion–positive NSCLC: A retrospective chart reviewMakenzi Evangelist, MDPublication #e20731Lung Cancer—Non-Small Cell Metastatic
REZLIDHIA (olutasidenib)Acute myeloid leukemia (AML) patient, disease, and molecular characteristics associated with a long-term (LT) response to olutasidenibJustin M. Watts, MDPoster presentation #6523Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and AllotransplantMonday, June 1, 20269:00am – 12:00pmReal-World Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using EHR DataYasmin Abaza, MDPublication #e18514Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using Real-World Data from Chart ReviewPinkal Desai, MD, MPHPublication #e18527Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Evaluating the cost per month of response for olutasidenib (OLU) versus ivosidenib (IVO) for patients with relapsed/refractory (R/R) mutant IDH1 (mIDH1) acute myeloid leukaemia (AML)Yasmin Abaza, MDPublication #e18504Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
EHA Presentations Abstract TitleLead Author / PresenterPresentation Type / Abstract #Session Date / Time (CEST)REZLIDHIA (olutasidenib)Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using Real-World Data from Chart ReviewPinkal Desai, MD, MPHPoster presentation #PS1502Saturday, June 13, 2026 (18:45 - 19:45 CEST)Acute myeloid leukemia (AML) patient, disease, and molecular characteristics associated with a long-term (LT) response to olutasidenibStéphane de Botton, MD, PhDPoster presentation #PS1625Saturday, June 13, 2026 (18:45 - 19:45 CEST)Delphi Consensus on Optimal Treatment Strategies Using IDH1 Inhibitors in Patients with R/R mIDH1 AMLJustin M. Watts, MDPublication #PB2795
Real-World Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using EHR DataYasmin Abaza, MDPublication #PB2610
TAVALISSE (fostamatinib disodium hexahydrate)Health-Related Quality of Life (HRQoL) Among Patients With Immune Thrombocytopenia (ITP) Treated With Fostamatinib in the FORTE StudyAmber Afzal, MD, MSCIPublication #PB4295
About NSCLC
It is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. Lung cancer is the leading cause of cancer death in the U.S., with non-small cell lung cancer (NSCLC) being the most common type accounting for 77% of all lung cancer diagnoses.1 RET fusions are implicated in approximately 1-2% of patients with NSCLC.2About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,720 new cases in the United States, most in adults, in 2026.3Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.4,5 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.6 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.About ITP
In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.About GAVRETO® (pralsetinib)INDICATIONSGAVRETO (pralsetinib) is indicated for the treatment of:Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved testAdult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)**This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).IMPORTANT SAFETY INFORMATIONWARNING: SERIOUS INFECTIONS, INCLUDING OPPPORTUNISTIC INFECTIONSGAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity.WARNINGS AND PRECAUTIONSSerious Infections, Including Opportunistic Infections: GAVRETO may increase the risk for serious infections, including fatal and opportunistic infections. In the AcceleRET-Lung trial, infections occurred in 72% of patients who received GAVRETO, including 18% with Grade 3 and 3.7% with Grade 4 and 7% with fatal outcomes. Among the patients who received chemotherapy/immunotherapy, infections occurred in 52%, including 10% with Grade 3. Infections in the GAVRETO arm included pneumonia, urinary tract infection, opportunistic infections (such as pneumocystis jirovecii pneumonia and fungal infections) and others. Monitor patients for signs and symptoms of infection and treat appropriately. Withhold, reduce the dose, or permanently discontinue GAVRETO based on severity.Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis can occur in patients treated with GAVRETO. Pneumonitis occurred in 12% of patients who received GAVRETO, including 3.3% with Grade 3-4, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of con?rmed ILD.Hypertension: Occurred in 35% of patients, including Grade 3 hypertension in 18% of patients. Overall, 8% had their dose interrupted and 4.8% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.Hepatotoxicity: Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 49% of patients, including Grade 3 or 4 in 7% and increased alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%. The median time to ?rst onset for increased AST was 15 days (range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the ?rst 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity.Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred in 4.1% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established.Embryo-Fetal Toxicity: Based on ?ndings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the last dose.ADVERSE REACTIONSCommon adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and increased bilirubin.DRUG INTERACTIONSAvoid coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong or moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose.Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur.Click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING.About REZLIDHIA®INDICATION
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.IMPORTANT SAFETY INFORMATION WARNING: DIFFERENTIATION SYNDROMEDifferentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution.WARNINGS AND PRECAUTIONSDifferentiation Syndrome
REZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients, with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA initiation and has been observed with or without concomitant leukocytosis.If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold dose of REZLIDHIA and consider dose reduction based on recurrence.Hepatotoxicity
REZLIDHIA can cause hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The median time to onset of hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day to 17.5 months) after REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.Monitor patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once in the fourth month, and once every other month for the duration of therapy. If hepatic dysfunction occurs, withhold, reduce, or permanently discontinue REZLIDHIA based on recurrence/severity.ADVERSE REACTIONS
The most common (≥20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and transaminitis.DRUG INTERACTIONSAvoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers.Avoid concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise instructed in the substrates prescribing information. If concomitant use is unavoidable, monitor patients for loss of therapeutic effect of these drugs.LACTATION
Advise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose.GERIATRIC USE
No overall differences in effectiveness were observed between patients 65 years and older and younger patients. Compared to patients younger than 65 years of age, an increase in incidence of hepatotoxicity and hypertension was observed in patients ≥65 years of age.HEPATIC IMPAIRMENT
In patients with mild or moderate hepatic impairment, closely monitor for increased probability of differentiation syndrome.Click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING.About TAVALISSE®
Indication
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.Important Safety InformationWarnings and PrecautionsHypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to ≥3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.Drug InteractionsConcomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.Adverse ReactionsSerious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.Click here for Important Safety Information and Full Prescribing Information.To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).GAVRETO, REZLIDHIA and TAVALISSE are registered trademarks of Rigel Pharmaceuticals, Inc.About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit www.rigel.com.The American Cancer Society. Key Statistics for Lung Cancer. Revised January 13, 2026. Accessed April 30, 2026: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.htmlKato, S. et al. RET Aberrations in Diverse Cancers: Next-Generation Sequencing of 4,871 Patients. Clin Cancer Res. 2017;23(8):1988-1997 doi: 10.1158/1078-0432.CCR-16-1679The American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Revised January 13, 2026. Accessed April 30, 2026: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.htmlPatel, A, et al. Outcomes of Patients With Acute Myeloid Leukemia Who Relapse After 5 Years of Complete Remission. 2021 Sep 7;28(7):811-814. doi: https://doi.org/10.3727/096504020X15965357399750Thol F, Ganser, A. Treatment of Relapsed Acute Myeloid Leukemia. Curr. Treat. Options on Oncol. (2020) 21: 66. doi: https://doi.org/10.1007/s11864-020-00765-5Thol F, Schlenk RF, Heuser M, Ganser A. How I treat refractory and early relapsed acute myeloid leukemia. Blood (2015) 126 (3): 319-27. doi: https://doi.org/10.1182/blood-2014-10-551911Forward Looking Statements
This press release contains forward-looking statements relating to, among other things, the presentation of data at the 2026 ASCO Annual Meeting and EHA2026 Congress, the potential therapeutic benefit and clinical utility of pralsetinib and olutasidenib, including the potential impact of treatment sequencing, and Rigel's expectations regarding the development and commercialization of its products and product candidates. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "look forward," "suggest," "may," "potential," "expect," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on Rigel's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks that clinical trial or real-world data may not be predictive of future clinical outcomes or results in broader patient populations; risks that further data, analyses or experience may alter current understanding of the safety, efficacy or therapeutic utility of pralsetinib or olutasidenib; risks associated with the timing, conduct and availability of data analyses and scientific presentations; risks associated with the commercialization and market acceptance of Rigel's products; and other risks described from time to time in Rigel's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and subsequent filings. Any forward-looking statement contained in this press release speaks only as of the date on which it was made. Rigel undertakes no obligation to update any forward-looking statements contained herein, except as required by law.Contact for Investors & Media:Investors:
Rigel Pharmaceuticals, Inc.
650.624.1232
ir@rigel.com Media:
David Rosen
Argot Partners
646.461.6387
david.rosen@argotpartners.com View original content to download multimedia:https://www.prnewswire.com/news-releases/rigel-announces-oral-and-poster-presentations-at-the-2026-asco-annual-meeting-and-eha2026-congress-302779594.htmlSOURCE Rigel Pharmaceuticals, Inc. Original: Rigel Announces Oral and Poster Presentations at the 2026 ASCO Annual Meeting and EHA2026 Congress
US Market News
2月前
Rigel Enters Exclusive Global Licensing Agreement for VEPPANU™ (vepdegestrant), an oral PROTAC, for the Treatment of 2L+ ER+/HER2-, ESR1m Advanced or Metastatic Breast CancerMay 12, 2026 7:00 AM
PR Newswire (US) VEPPANU has a novel mechanism of action, is the first and only FDA-approved PROTAC and has the potential to become an important new treatment option for adult patients with 2L+ ER+/HER2-, ESR1-mutated mBCPivotal Phase 3 VERITAC-2 clinical trial results showed that vepdegestrant was generally well tolerated and reported mPFS of 5.0 months vs. 2.1 months for fulvestrant, a 2.4-fold improvement, in patients with 2L+ ER+/HER2- mBC with an ESR1 mutationUpon closing of the transaction, VEPPANU will become Rigel's fourth commercial product and its major focus to accelerate revenue growth while leveraging the company's existing infrastructure, contributing meaningfully to the advancement of Rigel's transformational growth strategyArvinas and Pfizer will receive an upfront $70.0 million and an additional $15.0 million upon the successful completion of certain transition activities, and are eligible for up to $320.0 million in future potential regulatory and commercial milestones Rigel to host a conference call today at 8:00 a.m. Eastern Time to discuss the transaction and will be joined by breast cancer Key Opinion Leader and vepdegestrant Phase 3 VERITAC-2 principal investigator Erika Hamilton, M.D.SOUTH SAN FRANCISCO, Calif., May 12, 2026 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced that it has entered into an exclusive, global license agreement with Arvinas, Inc. (Arvinas) and Pfizer Inc. (Pfizer), subject to regulatory clearance, to develop, manufacture and commercialize VEPPANU™ (vepdegestrant), the first and only U.S. Food and Drug Administration (FDA)-approved oral PROteolysis TArgeting Chimera (PROTAC). PROTACs are part of a new class of heterobifunctional protein degraders designed to harness the body's natural machinery to selectively degrade, rather than inhibit, disease-causing proteins. In the Phase 3 VERITAC-2 clinical trial, which evaluated vepdegestrant in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer (mBC), vepdegestrant was generally well tolerated and demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as compared to fulvestrant."Our transformational growth strategy took a significant step forward today as we plan to enter a targeted segment of the sizable breast cancer market, focused on patients with limited treatment options following progression on endocrine therapy. With its novel mechanism of action designed to address a key driver of resistance, VEPPANU represents a compelling treatment option within this setting," said Raul Rodriguez, Rigel's president and CEO. "Importantly, we are well positioned to advance this important new treatment, supported by a highly experienced commercial and medical affairs organization and a proven track record of successfully launching newly-acquired assets. VEPPANU is expected to contribute strong revenue growth in our expanding commercial portfolio, and we believe it has the potential to become a meaningful driver of long-term growth for Rigel."On May 31, 2025, pivotal results for VERITAC-2 (NCT05654623), a global, randomized, open-label Phase 3 clinical trial were presented in an oral presentation of a late-breaking abstract at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, and simultaneously published in the New England Journal of Medicine. On August 8, 2025, the FDA accepted the New Drug Application (NDA) for vepdegestrant (ARV-471) to treat ER+/HER2-, ESR1-mutated advanced breast cancer and set a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.On May 1, 2026, VEPPANU (vepdegestrant) was approved by the FDA for the treatment of adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. FDA approval was granted based on data from VERITAC-2 clinical trial that evaluated vepdegestrant versus fulvestrant in patients with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. In the trial, among patients with an ESR1 mutation (n=270), vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 43% compared to fulvestrant. Median PFS was 5.0 months (95% CI: 3.7, 7.4) in the vepdegestrant arm and 2.1 months (95% CI: 1.9, 3.5) in the fulvestrant arm (hazard ratio 0.57 [95% CI: 0.42, 0.77]; p-value 0.0001). Overall survival was immature with 16% of deaths in this population at the time of the PFS analysis. The majority of adverse events with vepdegestrant were low grade (Grade 1-2) and the most common (≥10%) adverse reactions, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation."The ER+/HER2- patient population is the most prevalent breast cancer subtype, where treatment with endocrine therapies is the current standard of care. As many as 50% of patients emerge with an ESR1 mutation following exposure to endocrine therapy, developing resistance to standard treatments," said Erika Hamilton, M.D., Chief Development Officer, Late Phase and Director, Breast Cancer Research at Sarah Cannon Research Institute, and Phase 3 VERITAC-2 principal investigator. "As a PROTAC, vepdegestrant is mechanistically differentiated and has a demonstrated efficacy and a safety profile observed in clinical trials. Vepdegestrant provides a much-needed new treatment option for physicians that can fill a critical gap in care for patients with breast cancer."On May 8, 2026, the National Comprehensive Cancer Network® (NCCN®) added vepdegestrant to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer. Vepdegestrant was added as a Category 2A treatment option for patients with hormone receptor (HR)-positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitor.*Transaction Details
Under the terms of the agreement, Rigel will be granted exclusive global rights to develop, manufacture and commercialize VEPPANU. Arvinas and Pfizer will receive an upfront payment of $70.0 million and an additional $15.0 million upon successful completion of certain development and manufacturing transition activities, to be distributed to Arvinas and Pfizer.Pfizer and Arvinas will continue to be responsible for current ongoing development activities and Rigel will contribute up to $40.0 million towards certain development activities over the next four years.Arvinas and Pfizer are entitled to receive tiered royalties on commercial sales of VEPPANU ranging from mid-teens to mid-twenties. Arvinas and Pfizer are also eligible to receive a total of up to an additional $320.0 million in connection with the achievement of certain regulatory and commercial milestones.Rigel will be responsible for the launch and commercialization of VEPPANU in the U.S. and has global rights with the ability to sublicense to potential partners to further develop and commercialize vepdegestrant outside the U.S. Arvinas and Pfizer will be entitled to a percentage of sublicensing revenue generated outside the U.S.The effectiveness of the agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to close in mid-June 2026.Conference Call and Webcast with Slides Today at 8:00 a.m. Eastern Time
Rigel will hold a live conference call and webcast today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) to discuss the transaction. The conference call will also feature a presentation of the vepdegestrant Phase 3 data by Erika Hamilton, M.D., Chief Development Officer, Late Phase and Director, Breast Cancer Research at Sarah Cannon Research Institute, and Phase 3 VERITAC-2 principal investigator.Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.Please see below for the Important Safety Information for VEPPANU. Please see full U.S. Prescribing Information for VEPPANU here.What is VEPPANU?
VEPPANU is a prescription medicine to treat people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), and whose disease has progressed after at least one line of endocrine-based therapy.Your healthcare provider will perform a test to make sure that VEPPANU is right for you.It is not known if VEPPANU is safe and effective in children.IMPORTANT SAFETY INFORMATIONWhat should I tell my healthcare provider before taking VEPPANU?All your medical conditions, including if you:have heart failure or heart rhythm problems, including QTc prolongation, and long QTc syndromehave low blood levels of potassium or magnesiumare pregnant or plan to become pregnant. VEPPANU can harm your unborn baby.Females who are able to become pregnant:Your healthcare provider may do a pregnancy test before you start treatment with VEPPANU.Use effective birth control (contraception) during treatment with VEPPANU and for 2 weeks after the last dose.Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VEPPANU.Males with female partners who are able to become pregnant:Use effective birth control (contraception) during treatment with VEPPANU and for 2 weeks after the last dose.are breastfeeding or plan to breastfeed. It is not known if VEPPANU passes into your breast milk. Do not breastfeed during treatment with VEPPANU and for 2 weeks after the last dose.Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. VEPPANU and other medicines may affect the way each other works and may cause serious side effects.What should I avoid while taking VEPPANU?
Avoid taking St. John's wort, eating grapefruit, or drinking grapefruit juice during with treatment with VEPPANU.What are the possible side effects of VEPPANU?
VEPPANU can cause serious side effects, including:Heart rhythm problems (QTc interval prolongation). VEPPANU can cause changes in the electrical activity of your heart and may increase your risk of abnormal heart rhythm problems, and sudden death. Your healthcare provider will check your heart with a test called an electrocardiogram (ECG) and check your blood potassium and magnesium levels before and as needed during treatment with VEPPANU. Get emergency medical help right away if you get any signs and symptoms of abnormal heart rhythm, including:feeling lightheaded or faintdizzinessfeeling that your heart is pounding or beating fast (heart palpitations)shortness of breathchest painThe most common side effects of VEPPANU include:decreased white blood cell countsincreased liver function testsmuscle and bone paintirednessdecreased red blood cell countsnauseadecreased potassium levels in your blooddecreased appetiteabnormal electrocardiogram (QT prolonged)decreased platelet countsconstipationYour healthcare provider may decrease your dose, temporarily stop, or completely stop treatment with VEPPANU, if you develop certain side effects.VEPPANU may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of VEPPANU.Call your doctor for medical advice about side effects.To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).VEPPANU is a registered trademark of Arvinas Operations, Inc.About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit www.rigel.com.Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected closing of the transaction, the anticipated benefits of the license agreement, the potential of VEPPANU (vepdegestrant), and Rigel's expectations regarding the commercialization, market opportunity and potential contribution of VEPPANU to its commercial portfolio and future growth. These forward-looking statements are based upon Rigel's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to: the ability of the parties to satisfy the closing conditions to the transaction, including receipt of required regulatory approvals; the timing of the closing of the transaction; risks related to the transfer of development, manufacturing and commercialization responsibilities to Rigel, including risks associated with integrating newly acquired or licensed assets; Rigel's ability to successfully launch and commercialize VEPPANU, including uncertainties related to physician adoption, patient demand and market acceptance; the availability and adequacy of reimbursement and pricing; competition from other therapies; the extent to which clinical trial results translate into real-world outcomes; regulatory risks, including the risk that regulatory approvals may be subject to limitations or may be withdrawn; risks related to Rigel's dependence on third parties, including Arvinas and Pfizer, for development, manufacturing and supply activities; and Rigel's ability to successfully execute its strategic and commercial plans. There can be no assurance that VEPPANU will achieve the commercial potential anticipated by Rigel or that the transaction will result in the expected benefits. Additional risks and uncertainties are described in the "Risk Factors" section of Rigel's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and in other filings Rigel makes with the Securities and Exchange Commission. All forward-looking statements in this press release speak only as of the date of this release, and Rigel undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.Contact for Investors & Media:Investors:
Rigel Pharmaceuticals, Inc.
650.624.1232
ir@rigel.com Media:
David Rosen
Argot Partners
646.461.6387
david.rosen@argotpartners.com View original content to download multimedia:https://www.prnewswire.com/news-releases/rigel-enters-exclusive-global-licensing-agreement-for-veppanu-vepdegestrant-an-oral-protac-for-the-treatment-of-2l-erher2--esr1m-advanced-or-metastatic-breast-cancer-302769425.htmlSOURCE Rigel Pharmaceuticals, Inc. Original: Rigel Enters Exclusive Global Licensing Agreement for VEPPANU™ (vepdegestrant), an oral PROTAC, for the Treatment of 2L+ ER+/HER2-, ESR1m Advanced or Metastatic Breast Cancer
US Market News
3月前
Rigel Announces Publication of Final ARROW Clinical Trial Data on GAVRETO® (pralsetinib) in Patients with RET+ NSCLC in the Journal of Clinical OncologyMarch 31, 2026 8:05 AM
PR Newswire (US)
Pralsetinib induced robust and durable responses with a manageable safety profile, reinforcing the benefits of selective RET inhibitors in treating RET fusion-positive NSCLCSOUTH SAN FRANCISCO, Calif., March 31, 2026 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced publication of the final data from the Phase 1/2 ARROW study evaluating pralsetinib for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) in the Journal of Clinical Oncology. The final data includes an additional 42 months of follow-up from previously published data. Pralsetinib is the only once daily, oral RET-inhibitor therapy that is designed to selectively target RET in metastatic NSCLC and advanced or metastatic thyroid carcinoma. "The final data from the ARROW study shows robust and durable responses with a manageable safety profile in patients with RET fusion-positive NSCLC, emphasizing the importance of early biomarker testing and suggesting that pralsetinib may be a valuable tool in the treatment armamentarium," said Justin F. Gainor, M.D., Phase 1/2 trial investigator and Director of the Center for Thoracic Cancers at Mass General Brigham Cancer Institute. "In addition, the responses observed in the subset of patients with measurable CNS metastases at baseline further expand the potential clinical value of pralsetinib in everyday practice.""The results published in the Journal of Clinical Oncology demonstrate the positive impact pralsetinib can have for patients with RET fusion-positive NSCLC," said Lisa Rojkjaer, M.D, Rigel's chief medical officer. "These longer-term data further support pralsetinib's role as a first-line treatment option for RET fusion-positive NSCLC patients."Additional key points from the paper include:Consistent with previous reports from the ARROW study NSCLC cohort, pralsetinib was generally well tolerated with a manageable toxicity profile. Three treatment-related deaths occurred in treatment-naive patients in Asia (pneumonia, n=2; interstitial lung disease and rhabdomyolysis, n=1 each), no new safety signals were observed and no hypersensitivity reactions were reported in patients receiving prior immunotherapies.Among patients with measurable disease (n=259), the overall response rate (ORR) was 70%, including 7% complete responses and 63% partial responses.ORR was 78% among treatment-naïve patients and 63% among patients receiving prior platinum-based chemotherapy.At final data lock, median treatment duration was 15.0 months.Median overall survival (OS) was 44.3 months in the overall measurable disease patient population, 50.1 months in treatment-naïve patients, and 39.7 months in prior-platinum patients, with median follow-ups of 47.6, 43.7, and 49.7 months, respectively. Longer median OS in the overall measurable disease patient population was seen in patients treated in the United States (62.4 months) vs. Asia (44.5 months) or Europe (29.6 months).Median overall progression-free survival (PFS) was 13.1 months in the overall measurable disease patient population, but was longer in patients in the United States (25.9 months) vs. Asia (12.6 months) or Europe (12.8 months).ORR remained high in subgroups bearing the RET fusion partners KI5FB and CCDC6 among both treatment-naive and prior platinum-based chemotherapy patients. Among all patients, median duration of response (DOR) was longer in patients with CCDC6 (47.9 months) vs. KIF5B (13.1 months).Fifteen patients had measurable central nervous system (CNS) metastases at baseline. The intracranial response rate (CNS ORR) among these patients was 53%. In the 11 response-evaluable patients with CNS metastases, CNS ORR was 73%.The publication, titled "Final Efficacy and Safety Data From the Phase 1/2 ARROW Study of Pralsetinib in Patients With Advanced RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC)," was published online and can be found here.About NSCLC
It is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. Lung cancer is the leading cause of cancer death in the U.S., with non-small cell lung cancer (NSCLC) being the most common type accounting for 77% of all lung cancer diagnoses.1 RET fusions are implicated in approximately 1-2% of patients with NSCLC.2About GAVRETO® (pralsetinib)INDICATIONSGAVRETO (pralsetinib) is indicated for the treatment of:Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved testAdult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)**This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).IMPORTANT SAFETY INFORMATIONWARNING: SERIOUS INFECTIONS, INCLUDING OPPPORTUNISTIC INFECTIONSGAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity.WARNINGS AND PRECAUTIONSSerious Infections, Including Opportunistic Infections: GAVRETO may increase the risk for serious infections, including fatal and opportunistic infections. In the AcceleRET-Lung trial, infections occurred in 72% of patients who received GAVRETO, including 18% with Grade 3 and 3.7% with Grade 4 and 7% with fatal outcomes. Among the patients who received chemotherapy/immunotherapy, infections occurred in 52%, including 10% with Grade 3. Infections in the GAVRETO arm included pneumonia, urinary tract infection, opportunistic infections (such as pneumocystis jirovecii pneumonia and fungal infections) and others. Monitor patients for signs and symptoms of infection and treat appropriately. Withhold, reduce the dose, or permanently discontinue GAVRETO based on severity.Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis can occur in patients treated with GAVRETO. Pneumonitis occurred in 12% of patients who received GAVRETO, including 3.3% with Grade 3-4, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of con?rmed ILD.Hypertension: Occurred in 35% of patients, including Grade 3 hypertension in 18% of patients. Overall, 8% had their dose interrupted and 4.8% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.Hepatotoxicity: Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 49% of patients, including Grade 3 or 4 in 7% and increased alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%. The median time to ?rst onset for increased AST was 15 days (range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the ?rst 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity.Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred in 4.1% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established.Embryo-Fetal Toxicity: Based on ?ndings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the last dose.ADVERSE REACTIONSCommon adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and increased bilirubin.DRUG INTERACTIONSAvoid coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong or moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose.Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur.Click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING.To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).GAVRETO is a registered trademark of Rigel Pharmaceuticals, Inc.About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit www.rigel.com.The American Cancer Society. Key Statistics for Lung Cancer. Revised January 13, 2026. Accessed March 27, 2026: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.htmlKato, S. et al. RET Aberrations in Diverse Cancers: Next-Generation Sequencing of 4,871 Patients. Clin Cancer Res. 2017;23(8):1988-1997 doi: 10.1158/1078-0432.CCR-16-1679Forward-Looking Statements
This press release contains forward-looking statements relating to, among other things, the potential for the referenced clinical trial or trial results to strengthen our commercial portfolio, GAVRETO's success in treating RET fusion-positive NSCLC, and its role as a first-line treatment option for RET+ NSCLC patients. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "anticipates", "plan", "outlook", "potential", "may", "look to", "expects", "will", "initial", "promising", and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of pralsetinib; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding pralsetinib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that pralsetinib may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, and subsequent filings, including Quarterly Reports on Form 10-Q. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.Contact for Investors & Media:Investors:
Rigel Pharmaceuticals, Inc.
650.624.1232
ir@rigel.com Media:
David Rosen
Argot Partners
646.461.6387
david.rosen@argotpartners.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/rigel-announces-publication-of-final-arrow-clinical-trial-data-on-gavreto-pralsetinib-in-patients-with-ret-nsclc-in-the-journal-of-clinical-oncology-302729237.htmlSOURCE Rigel Pharmaceuticals, Inc.
Original: Rigel Announces Publication of Final ARROW Clinical Trial Data on GAVRETO® (pralsetinib) in Patients with RET+ NSCLC in the Journal of Clinical Oncology
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