Merck and Eisai’s Welireg Plus Lenvima Approved by FDA for Previously Treated Advanced Kidney Cancer
September 29, 2026
Source: drugdu
25
On September 25, Merck (MSD) and Eisai announced FDA approval of Welireg® (belzutifan), an oral HIF-2α inhibitor, in combination with Lenvima® (lenvatinib), for adults with advanced renal cell carcinoma (ccRCC) with a clear cell component previously treated with a PD-1 or PD-L1 inhibitor.
The approval is based on the LITESPARK-005 Phase 3 study, which showed the Welireg+Lenvima combination reduced the risk of disease progression or death by 30% versus cabozantinib. This provides a new all-oral option for patients after immunotherapy failure.
Source: https://www.merck.com/news/welireg-belzutifan-plus-lenvima-lenvatinib-reduced-the-risk-of-disease-progression-or-death-by-30-compared-to-cabozantinib-in-certain-previously-treated-patients-with-advanced-renal-ce/
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