Opinion granted based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial
First opinion to be granted for an anti-PD-1/L1 therapy in resectable non-small.
The sBLA is supported by data from the phase 3 NRG-GY018 trial, which included patients with stage III-IV or recurrent endometrial carcinoma whose cancer was either pMMR or dMMR.
FDA Grants Priority Review to Merck s Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
Merck (MRK) Granted FDA Priority Review for KEYTRUDA Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
Operator: Thank you for standing by. Welcome to the Merck & Co. Q4 Sales and Earnings Conference Call. [Operator Instructions] This call is being recorded.