FDA accepts for priority review the sBLA for Opdivo in patients with advanced renal cell carcinoma
The projected FDA action date is 16 March 2016.
Bristol-Myers Squibb Company (BMS) has announced that the FDA has accepted for filing and priority review a supplemental Biologics License Application (sBLA) for Opdivo for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo Breakthrough Therapy Designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prior therapy. The projected FDA action date is 16 March 2016.
Michael Giordano, senior vice president, head of Oncology Development, BMS, commented: “There remains a significant unmet medical need for advanced renal cell carcinoma patients who have received prior therapy and are often repeatedly treated with agents that are similar in mechanism. We are pleased the FDA has accepted our sBLA for Opdivo in RCC, and we will continue to work with urgency to bring Opdivo to patients with this cancer.”
This sBLA submission is based on CheckMate -025, a Phase III study that evaluated the overall survival of Opdivo in patients with previously treated advanced RCC versus everolimus, a current standard of care in this patient population. The trial was stopped early in July 2015 because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint of overall survival. Data from CheckMate -025 were recently presented at the 2015 European Cancer Congress and simultaneously published in The New England Journal of Medicine.
Related News
-
News Federal judge blocks Colorado's unprecedented price cap on Amgen's Enbrel
A US federal court has halted Colorado's attempt to impose a US$31,200 annual price cap on Amgen's arthritis drug Enbrel, ruling that the pharmaceutical company would likely suffer irreparable harm. The decision represents a significant blow to... -
.png)
News Protecting life-saving therapies: CPHI Online Podcast Series
The latest episode of the CPHI Podcast Series dives into a critical challenge facing the pharmaceutical industry: ensuring the integrity of temperature-sensitive medications and biologics through advanced predictive technology.
-
News 2026 Outsourcing Outlook Update - pharma at a crossroads
The pharmaceutical contract development and manufacturing organisation (CDMO) sector is experiencing unprecedented transformation, driven by evolving therapeutic complexities, geopolitical tensions, and the growing demand for specialised manufacturing ... -
News Roche maintains German investment commitment whilst rivals scale back
Pharmaceutical giant Roche has reaffirmed its commitment to investing in Germany, standing firm even as competitors Eli Lilly and Boehringer Ingelheim dramatically reduce their planned investments in response to controversial healthcare reforms.
-
News Women in Pharma: The History of CPHI Women in Japan
Our monthly Women in Pharma series highlights the influential lives and work of impactful women working across the pharmaceutical industry, and how the industry can work towards making the healthcare industry and workplace more equitable and inclusive. -
News EU drafts deal to end essential medicines shortage
European negotiators have agreed new legislation to tackle persistent shortages of essential medicines by prioritising supply security over price in public procurement and supporting domestic pharmaceutical manufacturing with strategic funding.
-
News Thermo Fisher Scientific offloads microbiology business to PE firm Astorg
The life sciences giant is divesting its global microbiology unit, which generated $645 million in revenue last year, to the pan-European private equity firm as part of an active portfolio management strategy. The transaction is expected to close in th... -
News The Shift: Why Sustainability is Moving to the Centre of CPHI Milan 2026
CPHI Online contributor David Roach takes a look at how conversations around sustainability in the pharmaceutical industry can and must be transformed into actionable deliveries, and what the inaugural CPHI Sustainability Summit means for the industry.