11.18.15
Bristol-Myers Squibb said that the U.S. Food and Drug Administration (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 March 16, 2016.
"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,” said Michael Giordano, senior vice president, head of oncology development, Bristol-Myers Squibb. “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.
"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,” said Michael Giordano, senior vice president, head of oncology development, Bristol-Myers Squibb. “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.
