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).
Kromek collaborates on next-gen CT detector technology
Gilead Sciences initiates Phase 2 trial in Europe to evaluate lenacapavir for HIV prevention
European Commission grants authorisation to ViiV Healthcare's Apretude for prevention of HIV
Celanese to supply VitalDose drug delivery platform for Population Council's MPT Intravaginal Ring
Henry Schein introduces equipment repair subscription - Henry Schein Thrive Service Plus
Seres Therapeutics provides business updates and reports Q2 2023 financial results