FDA Approves Opdivo for Patients with Head and Neck Cancer

The FDA has approved Opdivo (nivolumab) by Bristol-Myers Squibb for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The injection is indicated for patients with disease progression on or after platinum-based therapy.

The FDA approval was based on results from a phase 3 trial that examined how the drug worked in patients with recurrent or metastatic SCCHN with tumor progression during or within 6 months of receiving a platinum-based therapy. Opdivo is the first and only immuno-oncology treatment proven in a phase 3 trial to significantly extend overall survival.

“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,” said Maura Gillison, MD, PhD, lead investigator, 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.”

The US National Comprehensive Cancer Network (NCCN) updated its guidelines in October to include treatment with Opdivo as the only category 1 single-agent therapy for certain patients in this setting. Opdivo has now been approved in 5 tumor types in under 2 years.

“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,” said Chris Boerner, Head of US Commercial, Bristol-Myers Squibb, in a press release.

The most common adverse reactions associated with Opdivo are rash, fatigue, musculoskeletal pain, nausea, and diarrhea. Some of the recurring serious side effects are pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.