FDA accepts Merck and Eisai sNDAs for Welireg plus Lenvima in advanced RCC

Reuters02-28
FDA accepts Merck and Eisai sNDAs for Welireg plus Lenvima in advanced RCC

Merck and Eisai said the U.S. Food and Drug Administration has accepted for review two supplemental New Drug Applications seeking approval of WELIREG (belzutifan) plus LENVIMA (lenvatinib) for adult patients with advanced renal cell carcinoma with a clear cell component following a PD-1 or PD-L1 inhibitor. The FDA set a PDUFA target action date of Oct. 4, 2026 for both applications.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Merck & Co. Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260228417897) on February 28, 2026, and is solely responsible for the information contained therein.

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