Opdivo Granted Breakthrough Therapy Designation for Head and Neck Cancer

The FDA granted Breakthrough Therapy Designation to nivolumab (Opdivo) for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy.

The decision is based on results from a phase 3, open label, randomized trial called CheckMate-141. The trial evaluated Opdivo versus investigator’s choice of therapy in recurrent or metastatic SCCHN patients with tumor progression within 6 months of platinum therapies in the adjuvant, primary, recurrent or metastatic setting.

The independent Data Monitoring Committee concluded the study met its primary endpoint of overall survival, stopping the study early in January 2016.

“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,” said Jean Viallet, MD, global clinical research lead, Oncology, Bristol-Myers Squibb.

This is the fifth Breakthrough Therapy Designation granted for Opdivo. The 4 prior breakthrough therapy designation indications included patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab; previously treated advanced melanoma; previously treated non-squamous non-small cell lung cancer; and advanced or metastatic renal cell carcinoma.