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FDA grants Keytruda priority review for Merkel cell carcinoma
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The FDA granted priority review designation to a supplemental biologics license application of pembrolizumab for the treatment of pediatric and adult patients with locally recurrent advanced or metastatic Merkel cell carcinoma, according to the agent’s manufacturer.
Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — is indicated for the treatment of certain patients with melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, Hodgkin lymphoma, urothelial carcinoma and gastric cancer.
The FDA based the priority review designation for the treatment of Merkel cell carcinoma on overall response rate and duration of response data from the phase 2 KEYNOTE-017 trial.
Investigators presented results from the trial at the ASCO Annual Meeting in June.
“Merkel cell carcinoma, a rare type of skin cancer, is an aggressive and fast-growing disease that has been associated with mortality rates higher than other types of skin cancer, including melanoma,” Scot Ebbinghaus, MD, vice president of clinical research at Merck Research Laboratories, said in a company-issued press release. “KEYNOTE-017 represents the longest observation to date of patients with advanced Merkel cell carcinoma receiving anti-PD-1 therapy in the first-line setting, and demonstrated durable tumor control in these patients. We look forward to working closely with the FDA throughout the review process and to bringing Keytruda to patients with Merkel cell carcinoma.”
The FDA set an action date of Dec. 28.