BMS's Opdivo receives Breakthrough Therapy Designation from FDA for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck

Designation signals the urgent need for new treatment approaches in recurrent or metastatic squamous cell carcinoma of the head and neck after platinum based therapy.

The designation is based on results of CheckMate -141, a Phase III, open-label, randomized trial evaluating Opdivo versus investigator’s choice of therapy in patients with recurrent or metastatic SCCHN with tumour 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, Global Clinical Research Lead, Oncology, BMS, 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.”

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 fifth Breakthrough Therapy Designation granted for Opdivo by the FDA, with previous Breakthrough Therapy Designation indications including 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.