Posted by Michael Wonder on 08 Jun 2023
FDA accepts application for Merck’s Keytruda (pembrolizumab) plus chemotherapy as treatment for advanced or unresectable biliary tract cancer
8 June 2023 - Acceptance based on results from the Phase 3 KEYNOTE-966 trial, which showed a significant overall survival benefit in these patients.
Merck today announced the US FDA has accepted for review a new supplemental biologics license application seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.
