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FDA grants Keytruda priority review for treatment of HNSCC
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The FDA granted priority review to pembrolizumab for the treatment of recurrent or metastatic head and neck squamous cell carcinoma.
Pembrolizumab (Keytruda, Merck) — an anti-PD1 therapy to be administered intravenously at a dose of 200 mg every 3 weeks — will be reviewed as a single agent to treat patients with disease progression on or after platinum-containing chemotherapy.
“Starting in the early days of our development program, we have explored the role of Keytruda for patients with head and neck cancer, a difficult-to-treat and debilitating disease with very few treatment options,” Roger Dansey, MD, senior vice president and therapeutic area head of oncology late-stage development at Merck Research Laboratories, said in a company-issued press release. “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 Keytruda available to these patients.”
Pembrolizumab is indicated in the United States to treat patients with unresectable or metastatic melanoma. It is also approved for patients with metastatic non–small cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test; however, continued approval for this indication may be contingent upon verification and description of clinical benefit from confirmatory trials.
The target action date for the HNSCC indication is Aug. 9, and the application will be reviewed under the accelerated approval program, according to the press release.