The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to Bristol-Myers Squibb’s Opdivo to treat advanced or metastatic renal cell carcinoma. The Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible.
This designation is based on results of a Phase 3 study, CheckMate -025, 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 (DMC) concluded that the study met its primary endpoint of overall survival, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. Bristol-Myers Squibb will be presenting further data from this study at the upcoming 2015 European Cancer Congress.
According to the FDA, the criteria for Breakthrough Therapy Designation requires preliminary clinical evidence that demonstrates the medicine may have substantial improvement on at least one clinically significant endpoint over available therapy. 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.