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FDA Grants Breakthrough Designation to Nivolumab in Squamous Cell Carcinoma of the Head and Neck

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On April 25, 2016, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to the anti–programmed death 1 antibody nivolumab (Opdivo) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck that previously received platinum-based therapy.

The FDA based its decision on results of the phase III Checkmate-141 trial, an open-label, randomized trial that evaluated nivolumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck whose tumors progressed within 6 months of platinum therapies in the adjuvant, primary, recurrent, or metastatic setting. Researchers assigned patients to nivolumab or investigator’s choice of therapy. The trial met its primary endpoint of overall survival, and the study concluded in January.

“The breakthrough therapy designation for [nivolumab] in advanced [squamous cell carcinoma of the head and neck] underscores the immediate need for new treatment approaches for this devastating disease, and reflects our commitment to advancing immuno-oncology research with the goal of addressing hard-to-treat cancers and changing survival expectations for patients,” said Jean Viallet, MD, Global Clinical Research Lead of Oncology at Bristol-Myers Squibb.

The FDA previously granted breakthrough therapy designation to nivolumab for four other indications: patients with Hodgkin lymphoma who failed autologous stem cell transplant and brentuximab vedotin (Adcetris); those with previously treated advanced melanoma; patients with previously treated nonsquamous non–small cell lung cancer; and individuals with advanced or metastatic renal cell carcinoma.

Nivolumab is approved for single-agent treatment of patients with BRAF V600 wild-type and BRAF V600–positive unresectable or metastatic melanoma. It also is approved for treatment of patients with metastatic non–small cell lung cancer that progressed on or after platinum-based chemotherapy, as well as for the treatment of patients with advanced renal cell carcinoma who received prior antiangiogenic therapy.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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