Priority Review Granted by FDA to Pembrolizumab in Merkel Cell Carcinoma
Posted: Friday, September 7, 2018
On September 4, 2018, the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental biologics license application seeking accelerated approval for pembrolizumab (Keytruda) in the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
This priority review is based on data from the phase II KEYNOTE-017 trial (ClinicalTrials.gov identifier NCT02267603), including overall response rate and duration of response; these data were presented earlier this year at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 9506).
In July 2017, pembrolizumab was granted Breakthrough Therapy designation by the FDA for this indication. The FDA has set a Prescription Drug User Fee Act, or target action, date of December 28, 2018.
