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The FDA has approved nivolumab (Opdivo) injection, for IV use, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.

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Nivolumab is the first and only immuno-oncology treatment proven in a phase III trial to significantly extend overall survival (OS) for these patients. The approval was based on results from the phase III, CheckMate-141 trial in which nivolumab demonstrated statistically significant and clinically meaningful superior OS versus the comparator arm (investigator's choice of methotrexate, docetaxel or cetuximab), with a 30 percent reduction in the risk of death (HR=0.70 [95% CI: 0.53-0.92; p=0.0101]).


The median OS was 7.5 months (95% CI: 5.5-9.1) for nivolumab compared to 5.1 months (95% CI: 4.0-6.0) for investigator's choice. Nivolumab is associated with immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; and embryo-fetal toxicity.


"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, Jeg Coughlin Chair of Cancer Research, The Ohio State University Wexner Medical Center. "This latest approval for Opdivo reinforces the potential to provide patients with improved overall survival, considered the gold standard in cancer care."