FDA Accepts Supplemental Biologics License Application for Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer, Grants Priority Review
Merck today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), a monoclonal antibody and anti–programmed cell death 1 (PD-1) therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. The application is seeking approval for pembrolizumab as a single agent at a dose of 200 mg administered intravenously every 3 weeks. The FDA granted Priority Review with a PDUFA, or target action, date of August 9; the sBLA will be reviewed under the FDA’s Accelerated Approval program.
“Starting in the early days of our development program, we have explored the role of [pembrolizumab] for patients with head and neck cancer, a difficult-to-treat and debilitating disease with very few treatment options,” said Roger Dansey, MD, Senior Vice President and Therapeutic Area Head, Oncology Late-Stage Development, Merck Research Laboratories. “We are encouraged by the data emerging from our program in this type of cancer, and welcome today’s news as this is an important step toward making [pembrolizumab] available to these patients.”
About Pembrolizumab
Pembrolizumanb is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Pembrolizumab blocks the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.
Pembrolizumab is indicated in the United States for the treatment of patients with unresectable or metastatic melanoma. The drug is also in
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