FDA grants Keytruda priority review for Merkel cell carcinoma

Source: Healio, September 2018

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.