SweepsMcGee
7年前
BeiGene Announces Approval of REVLIMID® for Newly Diagnosed Multiple Myeloma in China
BEIJING, China, and CAMBRIDGE, Mass., Feb. 27, 2018 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, today announced that REVLIMID® (lenalidomide) has been approved by the China Food and Drug Administration (CFDA) for the treatment of multiple myeloma (MM) in combination with dexamethasone in adult patients with previously untreated MM who are not eligible for transplant. REVLIMID is an oral immunomodulatory drug that was first approved by the CFDA in China in 2013 for the treatment of MM in combination with dexamethasone, in adult patients who have received at least one prior therapy. It is currently marketed in China by BeiGene under an exclusive license from Celgene Corporation.
“REVLIMID is an important part of our commercial and development plans in China, where we are expanding our portfolio and commercial footprint. In China, where the incidence of multiple myeloma is on the rise due to an aging population and improved diagnosis, we are hopeful that newly diagnosed patients will have a meaningful long-term benefit from this approval,” commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.
In a large randomized, three-arm, open-label Phase 3 trial (CC-5013-MM-020) conducted to compare the efficacy and safety of REVLIMID and low dose dexamethasone (Rd) to that of melphalan, prednisone and thalidomide (MPT) in patients with newly diagnosed multiple myeloma (NDMM) who were not eligible for transplant, continuous REVLIMID plus dexamethasone (Rd continuous) significantly improved median progression-free survival (PFS) compared to the MPT arm with a hazard ratio (HR) of 0.72 (95% Confidence Interval (CI): 0.61-0.85, p <0.0001) and a median PFS of 25.5 vs. 21.2 months. The median overall survival was 10.4 months longer with Rd continuous vs. MPT (58.9 vs. 48.5 months, HR of 0.75 (95% CI: 0.62-0.90)). Similarly, the response rate was also higher with Rd continuous compared with MPT (75.1% vs. 62.3%); with a complete response in 15.1% of Rd continuous arm patients vs. 9.3% in the MPT arm.
The most common grade 3/4 adverse events (occurring in ≥ 10% of patients in any subgroup) in the Rd continuous arm, Rd for 72 weeks (18 cycles; Rd18 arm) or MPT arm in the trial included neutropenia (28%, 27%, 45%, respectively), anemia (18%, 16%, 19%), thrombocytopenia (8%, 8%,11%) and pneumonia (11%, 11%, 8%).
About Multiple Myeloma
Multiple myeloma is an incurable and life-threatening blood cancer that is characterized by tumor proliferation and suppression of the immune system.i It can appear as both a tumor and/or an area of bone loss, and it affects the places where bone marrow is active in an adult: the hollow area within the bones of the spine, skull, pelvis, rib cage, and the areas around the shoulders and hips.ii MM is the second most commonly diagnosed blood cancer. According to the International Myeloma Foundation, there are an estimated 750,000 MM patients worldwide.iii
About REVLIMID
In China, REVLIMID is now approved in combination with dexamethasone for the treatment of adult NDMM patients who are not eligible for transplant. It received approval in China in 2013 for the treatment of MM in combination with dexamethasone, in adult patients who have received at least one prior therapy.
REVLIMID, in combination with dexamethasone, is approved in the United States, in Europe, in Japan and in around 25 other countries for the treatment of adult patients with previously untreated MM who are not eligible for transplant. REVLIMID is also approved in combination with dexamethasone for the treatment of MM patients who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
In addition, REVLIMID is approved in the United States and Europe for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.
REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.
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