Posted by Michael Wonder on 16 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for advanced renal cell carcinoma
15 February 2019 - Application based on overall survival and progression-free survival data from Phase 3 KEYNOTE-426 trial.
Merck today announced that the U.S. FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for Keytruda, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma.
This sBLA is based on findings from the Phase 3 KEYNOTE-426 trial, which demonstrated that KEYTRUDA in combination with axitinib, as compared to sunitinib, significantly improved overall survival (OS) and progression-free-survival (PFS) in the first-line treatment of advanced RCC. These data will be presented at the 2019 Genitourinary Cancers Symposium in San Francisco on February 16. The sBLA also included supporting data from the Phase 1b KEYNOTE-035 trial.
The FDA has set a Prescription Drug User Fee Act, or target action, date of 30 June 2019.
