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16 Sep 2015

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

This is the fourth Breakthrough Therapy Designation granted for Opdivo by the FDA

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.

Michael Giordano, senior vice president, head of Development, Oncology commented: “Results from CheckMate -025 mark the third tumor in which Opdivo has shown an overall survival benefit in a Phase III trial. The Breakthrough Therapy Designation in advanced renal cell carcinoma is a clear signal of the need for additional treatment approaches for RCC and reflects part of our broad commitment to Immuno-Oncology research that may address many types of advanced cancers."

This is the fourth Breakthrough Therapy Designation granted for Opdivo by the FDA, with previous indications including patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab, previously treated advanced melanoma, and previously treated non-squamous non-small cell lung cancer.

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