23 January 2020 - 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 Health Canada has approved Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for first-line treatment of patients with advanced renal cell carcinoma.
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 for Keytruda in combination with compared to sunitinib.