Posted by Michael Wonder on 20 Feb 2024
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as treatment for primary advanced or recurrent endometrial carcinoma
20 February 2024 - Acceptance based on results from the pivotal Phase 3 NRG-GY018 trial.
Merck today announced the US FDA has accepted for priority review a new supplemental biologics license application seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel), followed by Keytruda as a single agent for the treatment of patients with primary advanced or recurrent endometrial carcinoma.
