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European Commission Approves KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) as First-Line Treatment for Adult Patients With Advanced Renal Cell Carcinoma

Published: 2021-11-29 11:45:00 ET
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Approval Based on Results From CLEAR/KEYNOTE-581 Trial Demonstrating KEYTRUDA Plus LENVIMA Significantly Reduced the Risk of Disease Progression or Death by 61%, With a Median Progression-Free Survival of Nearly Two Years Versus Nine Months for Sunitinib

KENILWORTH, N.J. & TOKYO--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the European Commission has approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA (KISPLYX® in the European Union [EU] for the treatment of advanced renal cell carcinoma [RCC]), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the first-line treatment of adult patients with advanced RCC.

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The approval for advanced RCC is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival (PFS), reducing the risk of disease progression or death by 61% (HR=0.39 [95% CI, 0.32-0.49]; p