Research & Development
FDA Approves Merck's Keytruda in Combination with Inlyta as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
23 April 2019 - - The US Food and Drug Administration has approved Keytruda, US-based pharmaceutical company Merck's (NYSE: MRK) 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, the company said.

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 axitinib (Keytruda-axitinib combination) compared to sunitinib.

Consistent results were observed across pre-specified subgroups, IMDC risk categories and PD-L1 tumor expression status.

For the main efficacy outcome measures of OS and PFS, the Keytruda-axitinib combination reduced the risk of death by 47% compared to sunitinib (HR=0.53 [95% CI, 0.38-0.74]; p
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