Therapy Areas: AIDS & HIV
Bristol-Myers Squibb sBLA for Opdivo plus Yervoy in Cetain Renal Cell Carcinoma Patients Accepted for Review by US FDA
14 December 2017 - - The US Food and Drug Administration has accepted New York, New York-based biopharmaceutical company Bristol-Myers Squibb's (BMS) (NYSE: BMY) supplemental biologics license application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC), the company said.
The application has an action date of April 16, 2018.
The sBLA is based on data from the phase 3 CheckMate -214 study, which was stopped early based on the recommendation of an independent Data Monitoring Committee following a planned interim analysis of overall survival.
CheckMate -214 is a phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic RCC.
The study met the co-primary endpoints of improved overall survival and objective response rate compared to sunitinib in intermediate- and poor-risk patients.
While the combination demonstrated an improvement in progression-free survival relative to sunitinib, another co-primary endpoint, it did not reach statistical significance.
Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. Opdivo's leading global development program includes a broad range of clinical trials across all phases, including Phase 3, in a range of tumor types.
To date, the Opdivo clinical development program has enrolled more than 25,000 patients.
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, and distributes biopharmaceutical products worldwide.
The company offers chemically-synthesized drug and biologic in various therapeutic areas, such as oncology; cardiovascular; immunoscience; and virology comprising human immunodeficiency virus infection (HIV).
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