BMS’s Opdivo (nivolumab) receives breakthrough therapy designation from FDA for advanced renal cell carcinoma

Bristol-Myers Squibb Company (BMS) has announced that FDA has granted Breakthrough Therapy Designation to Opdivo for the potential indication of advanced or metastatic renal cell carcinoma (RCC).

This designation is based on results of CheckMate -025, a Phase III study that evaluated the survival of patients with previously treated advanced or metastatic clear-cell RCC versus everolimus, a current standard of care for patients with previously treated kidney cancer. The trial was stopped early in July 2015 because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint of overall survival, demonstrating superior overall survival in patients receiving Opdivo compared with the control arm. BMS Squibb will be presenting further data from this study at the upcoming 2015 European Cancer Congress (ECC), and looks forward to submitting these data to regulatory authorities this year.