FDA Grants Priority Review to Pembrolizumab for Advanced Merkel Cell Carcinoma

The Food and Drug Administration (FDA) granted priority review to pembrolizumab (Keytruda) for the treatment of adults and children with recurrent locally advanced or metastatic Merkel cell carcinoma, according to Merck, the agent’s manufacturer.

Pembrolizumab 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). This activates T lymphocytes which could affect both tumor cells and healthy cells.

The priority review was based on 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.

“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 statement. “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,” he added.

The agency granted pembrolizumab breakthrough therapy designation for this indication in July and has set a Prescription Drug User Fee Act (PDUFA) date for Dec. 28.