publication date: Jul. 2, 2015
EMA Grants Approval to Opdivo in Melanoma
The European Medicines Agency granted accelerated approval to Opdivo (nivolumab) for the treatment of metastatic melanoma.
Opdivo is a monoclonal antibody that targets the programmed cell death 1 receptor expressed on T cells. PD-1 functions to suppress T cell activity and Opdivo blocks this suppression releasing the T cells to mediate tumor regression. Two PD-1 targeted agents, Opdivo and pembrolizumab, were approved by FDA for the treatment of advanced melanoma in 2014.
The accelerated EMA approval is based on the results of CheckMate-066 and CheckMate-037 trials, which involved treatment-naïve and pre-treated melanoma patients, respectively. Opdivo is sponsored by Bristol-Myers Squibb.
CheckMate-066 revealed 73 percent one-year survival rate in patients treated with Opdivo, compared to 42 percent in those treated with comparator drug, dacarbazine.
In CheckMate-037, the combination of Opdivo and Yervoy (ipilimumab)—plus a BRAF inhibitor in patients who were BRAF-positive—achieved an objective response rate of 32 percent, compared to 11 percent among patients treated with conventional chemotherapy alone.
The Leukemia & Lymphoma Society accelerated a portion of the final payment linked to the phase III study of CPX-351 (cytarabine:daunorubicin) liposome injection, Celator Pharmaceuticals’ lead product candidate, for the treatment of patients with high-risk acute myeloid leukemia.
LLS has moved forward payment of $400,000 originally attached to the final overall survival analysis milestone and added it to the milestone payment for induction response rate analysis, thereby increasing the payment from the original amount of $500,000 … Continue reading 41-26 EMA Grants Approval to Opdivo in Melanoma
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