FDA Approves Opdivo for Head and Neck Cancer Patients

The FDA has approved Opdivo (nivolumab; Bristol-Myers Squibb) injection as the first single-agent therapy for patients with metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN) whose disease progressed during or after platinum-based therapy, according to a press release from the drug’s manufacturer.

This approval is based on recent phase 3 trial data, which found significantly increased overall survival rates among treatment-experienced SCCHN patients who received the new therapy.

“Squamous cell carcinoma of the head and neck that progresses on or after platinum-based therapy is a debilitating and hard-to-treat disease associated with a very poor prognosis,” Maura Gillison, MD, PhD, Jeg Coughlin Chair of Cancer Research at Ohio State University’s Wexner Medical Center, said in a press release. “This latest approval for Opdivo reinforces the potential to provide patients with improved overall survival, considered the gold standard in cancer care.”

In the CheckMate -141 trial, Dr. Gillison and colleagues randomly assigned eligible patients to receive Opdivo, or therapy with methotrexate, docetaxel, or Erbitux (cetuximab; Merck). The researchers reported a 30% reduction in the risk of death and longer overall survival, but no significant differences in progression-free survival and objective response rate. 

Safety outcomes during CheckMate -141 were similar to those of prior studies of melanoma and non-small cell lung cancer patients, with serious adverse events occurring in 49% of patients receiving Opdivo. The most frequent serious adverse reactions included pneumonia, dyspnea, aspiration pneumonia, respiratory failure, respiratory tract infection, and sepsis.

According to the press release, Opdivo received Breakthrough Therapy Designation from the FDA in April, and in October was included as the only category 1 single-agent therapy recommended by the U.S. National Comprehensive Cancer Network for platinum therapy-experienced patients with recurrent or metastatic SCCHN. 

“With this approval in head and neck cancer, we continue to lead the field in bringing our immuno-oncology science and the potential for increasing survival to more people with cancer,” Chris Boerner, head of U.S. Commercial at Bristol-Myers Squibb, said in the press release. “We take tremendous pride in the unprecedented speed and rigor with which we have brought Opdivo to market to address unmet needs across more tumor types than any other immuno-oncology treatment.” —Dave Muoio