FDA Grants Keytruda Priority Review to Treat Rare Form of Skin Cancer

The Food and Drug Administration (FDA) granted priority review to a new supplemental biologics license application for Keytruda (pembrolizumab) to treat adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, according to Merck, the agent’s manufacturer.

“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, M.D., vice president of clinical research at Merck Research Laboratories, said in a statement.

Keytruda is an anti-PD-1 therapy designed to increase the immune system’s ability to detect and fight tumor cells by blocking the interaction between PD-1 and its ligands (a molecule that binds to another usually larger molecule), thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

The application included overall response rates and duration of responses from the phase 2 KEYNOTE-017 trial, which were presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in June.

“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,” Ebbinghaus added.

The agency granted Keytruda breakthrough therapy designation for this indication in July, and has set a target action date for Dec. 28.