Onco360® Has Been Selected as a National Specialty Pharmacy for crovalimab-akkz
2024年8月5日 - 9:30PM
Onco360®, the nation’s leading independent Specialty Pharmacy, has
been selected by Genentech, a member of the Roche Group, to be in
the pharmacy network for PIASKY(R) (crovalimab), approved for the
treatment of adult and pediatric patients 13 years of age and older
weighing at least 40kg, that have paroxysmal nocturnal
hemoglobinuria (PNH). This indication was approved based on the
Phase III COMMODORE-2 (NCT04434092) trial, which compared
crovalimab to eculizumab in patients with PNH who had not
been previously treated with complement inhibitor
therapy.1 Only healthcare providers should administer
crovalimab.
“Onco360 is grateful for the opportunity to become a specialty
pharmacy provider for crovalimab”, said Benito Fernandez, Chief
Commercial Officer. “We are proud to add another treatment option
for PNH patients to our portfolio.”
Patients with PNH have an acquired mutation that makes red blood
cells susceptible to premature destruction by the complement
system. PNH is characterized by bone marrow failure, hemolysis, and
thrombosis in varying levels of severity and combinations.2
The FDA approval of crovalimab is based on the results of the
Phase III COMMODORE-2 clinical trial which evaluated the
non-inferiority of the complement C5 inhibitor, crovalimab, against
eculizumab in PNH patients naive to treatment with C5 inhibitors.
The study randomized 204 patients 2:1 to receive either crovalimab
(n=135) or eculizumab (n=69). The coprimary endpoints were the
proportion of patients who achieved transfusion avoidance and the
proportion of patients with hemolysis control (measured by lactate
dehydrogenase of ≤ 1.5 x upper limit of normal), from baseline
through week 25. The results showed treatment with crovalimab met
both coprimary endpoints demonstrating noninferiority to eculizumab
for transfusion avoidance (65.7% vs 68.1%, respectively; treatment
difference, -2.8% [95% CI, -15.7, 11.1]) and hemolysis control
(79.3% vs 79.0%, respectively; odds ratio, 1.02 [95% CI,
0.57-1.82]).
The safety data for crovalimab is supported by the COMMODORE-2
trial and the COMMODORE 1 trial which randomized treatment
experienced patients to switch to crovalimab (n=44) or continue
eculizumab (n=42). Across these trials, the most common adverse
drug reactions occurring in 10% or more of patients were infusion
related reaction, respiratory tract infection, viral infection, and
Type III hypersensitivity reactions.
The prescribing information for crovalimab includes a Boxed
Warning regarding the risk of serious and life-threatening
infections caused by Neisseria meningitidis. Because of this risk,
crovalimab as part of a class of therapies that treats PNH, it is
available only through a restricted program called the PIASKY Risk
Evaluation and Mitigation Strategy (REMS). More information about
the PIASKY REMS program is available at PiaskyREMS.com.
Vaccinate against meningococcal infection at least 2 weeks prior
to initiation of crovalimab, or provide antibacterial drug
prophylaxis if urgent crovalimab therapy is indicated in a patient
who is not up to date with meningococcal vaccines and vaccinate as
soon as possible. The initiation of crovalimab treatment is
contraindicated in patients with unresolved Neisseria
meningitidis infection.
Please see the full Prescribing Information for crovalimab.
PIASKY(R) (crovalimab) is a registered trademark of Chugai
Pharmaceutical Co., a member of the Roche Group.
About Onco360 Oncology Pharmacy:Onco360 is the
nation’s largest independent Oncology Pharmacy and clinical support
services company. Onco360 was founded in 2003 to bring together the
stakeholders involved in the cancer treatment process and serve the
specialized needs of oncologists, patients, hospitals, cancer
centers of excellence, manufacturers, health plans, and payers. It
dispenses nationally through its network of URAC-, and
ACHC-accredited Specialty Pharmacies. Onco360 is headquartered in
Louisville, Kentucky, and is a flagship specialty pharmacy brand of
PharMerica Corporation, a leading institutional pharmacy, specialty
infusion, and hospital services company servicing healthcare
facilities in the United States. For more information about
Onco360, please visit Onco360.com.
Media Contact: Benito Fernandez, Chief
Commercial OfficerBenito.Fernandez@Onco360.com516-640-1332
References:
- Kulasekararaj, A et al. Phase III, Randomized, Open-Label,
Multicenter COMMODORE 2 Study Evaluating the Efficacy and Safety of
Crovalimab Versus Eculizumab in Adult and Adolescent Patients with
Paroxysmal Nocturnal Hemoglobinuria Not Previously Treated with
Complement Inhibitors. Blood 2020; 136 (Supplement 1):
34.
doi: https://doi-org.ezproxy.uky.edu/10.1182/blood-2020-136647
- Cançado RD, Araújo A da S, Sandes AF, et al. Consensus
statement for diagnosis and treatment of paroxysmal nocturnal
haemoglobinuria. Hematol Transfus Cell Ther. 2021;43(3):341-348.
doi:10.1016/j.htct.2020.06.006