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news.The US Food and Drug Administration (FDA) has accepted for filing and priority review a supplemental Biologics License Application (sBLA) for Bristol-Myers Squibb's Opdivo to treat patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
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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 March 16, 2016.
Bristol-Myers Squibb senior vice president, head of Oncology Development Michael Giordano said: "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 3 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.
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths worldwide each year. Clear-cell RCC is the most prevalent type of RCC and constitutes 80% to 90% of all cases. RCC is approximately twice as common in men as in women, with the highest rates of the disease found in North America and Europe. Globally, the five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%.
About Opdivo
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as monotherapy or in combination with other therapies – in which more than 8,000 patients have been enrolled worldwide. Opdivo is the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in more than 37 countries including the United States, Japan, and in the European Union.