BMS’ Opdivo Scores Breakthrough Designation

The FDA has granted a fifth breakthrough therapy designation to Bristol-Myers Squibb’s Opdivo for recurrent or metastatic squamous cell carcinoma of the head and neck following chemotherapy.

The decision was based on results from a pivotal trial in which the drug met its primary endpoint of overall survival.

Previously garnered indications are Hodgkin lymphoma following failure of autologous stem cell transplant and brentuximab, advanced melanoma, non-squamous non-small lung cancer and advanced metastatic renal cell carcinoma.