FDA Approves Opdivo in Head and Neck Squamous Cell Carcinoma

The FDA approved Opdivo immunotherapy for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck.

Developed by Bristol-Myers Squibb, Opdivo approval was based on an open-label Phase III trial, where Opdivo improved overall survival by 2.4 months compared to an investigator’s choice of either cetuximab, methotrexate or docetaxel chemotherapy.

Serious adverse reactions occurred in 49 percent of patients receiving Opdivo, according to the FDA; the most frequent being pneumonia, respiratory failure, respiratory tract infection, and sepsis.