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 R...
Merck & Company, Inc. (new) (MRK)
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Source: Business Wire
Application Based on Overall Survival and Progression-Free Survival Data from Phase 3 KEYNOTE-426 Trial KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (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 (RCC). 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 Sympo
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MRK
Earnings
- 4/25/24 - Beat
MRK
Sec Filings
- 4/25/24 - Form 8-K
- 4/11/24 - Form ARS
- 4/11/24 - Form DEFA14A
- MRK's page on the SEC website