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# FDA OKs Opdivo for Head/Neck Carcinoma
- URL: https://www.fdaweb.com/fda-oks-opdivo-for-head-neck-carcinoma/
- Published: 2016-11-10T12:00:00.000Z
- Updated: 2026-09-14T21:46:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137319

FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy. Approval was based on data from a randomized trial (CheckMate 141) comparing nivolumab with chemotherapy (cetuximab, methotrexate, or docetaxel) in patients with recurrent or metastatic SCCHN, an FDA release says. The trial demonstrated a statistically significant and clinically meaningful improvement in overall survival — 7.5 months for the nivolumab arm and 5.1 months for those on chemotherapy.

  
“Serious adverse reactions occurred in 49% of patients receiving nivolumab,” FDA says. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than IC were cough and dyspnea.