6 May 2021 - Applications based on progression-free survival, overall survival, and objective response rate data from respective pivotal Phase 3 trials.

Merck and Eisai today announced that the U.S. FDA has accepted and granted priority review for applications seeking two new approvals for the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. 

The first set of applications (a supplemental biologics license application for Keytruda and a supplemental new drug application for Lenvima) are for the first-line treatment of patients with advanced renal cell carcinoma, based on progression-free survival, overall survival and objective response rate data from the pivotal Phase 3 CLEAR trial (KEYNOTE-581/Study 307). 

The second set of applications are for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, based on progression-free survival, overall survival and overall response rate data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial. These are the first applications to be submitted in the U.S. for this combination therapy based on Phase 3 clinical data. 

The FDA has set Prescription Drug User Fee Act dates, or target action dates, of 25 August 2021 and 26 August 2021, for the advanced renal cell carcinoma supplemental new drug application and supplemental biologics license application applications, respectively, and 3 September 2021, for the advanced endometrial carcinoma applications.

Read Merck press release