Posted by Michael Wonder on 23 Apr 2019
FDA approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma
22 April 2019 - Approval based on results of KEYNOTE-426, where Keytruda in combination with axitinib reduced the risk of death by nearly half compared to sunitinib.
Merck today announced that the U.S. FDA has approved 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 (RCC).
The approval is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated significant improvements in overall survival, progression-free survival and objective response rate (ORR) for Keytruda in combination with axitinib (Keytruda-axitinib combination) compared to sunitinib.
