Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy. 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.
The designation is based on results of CheckMate -141, a Phase 3, open-label, randomized trial evaluating Opdivo versus investigator’s choice of therapy in patients with recurrent or metastatic SCCHN with tumor progression within six months of platinum therapies in the adjuvant, primary, recurrent or metastatic setting. This trial was stopped early in January 2016 because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint of overall survival.
Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb, commented, “The Breakthrough Therapy Designation for Opdivo in advanced squamous cell carcinoma of the head and neck underscores the immediate need for new treatment approaches for this devastating disease, and reflects our commitment to advancing Immuno-Oncology research with the goal of addressing hard-to-treat cancers and changing survival expectations for patients.”