Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Opdivo (nivolumab) for the potential indication of advanced or metastatic renal cell carcinoma (RCC).
This designation is based on results of CheckMate -025, a Phase 3 study that evaluated the survival of patients with previously treated advanced or metastatic clear-cell RCC vs. the standard therapy everolimus. The trial was halted early in July 2015 because the study met its primary endpoint of overall survival, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. Detailed results of the study will be presented at the upcoming 2015 European Cancer Congress (ECC), and will then be submitted to regulatory authorities this year.
This is the fourth Breakthrough Therapy designation granted to Opdivo by the FDA, with previous indications for 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 (NSCLC).
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor. It is currently indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor, and for the treatment of patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy.
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