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News|Articles|September 25, 2026
FDA Approves Belzutifan-Lenvatinib Combo for Advanced Kidney Cancer
Author(s)Brooke McCormick
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Key Takeaways
- FDA authorized belzutifan plus lenvatinib for advanced ccRCC in adults following progression on prior PD-1/PD-L1 inhibitor therapy.
- A first-in-class oral HIF-2α inhibitor is paired with an oral multi-receptor TKI, providing a non–IO-based combination strategy in later lines.
FDA approved belzutifan plus lenvatinib for advanced ccRCC after PD-1/PD-L1 therapy, expanding treatment options for those with disease progression.
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Yesterday, September 24, the FDA
Belzutifan is a first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, and lenvatibib is an orally available multi-receptor tyrosine kinase inhibitor (TKI). Today’s decision was
“While there has been much progress in the first-line treatment of advanced kidney cancer, we have limited options to offer patients if the disease progresses after treatment with a PD-1/PD-L1 immunotherapy,” Robert Motzer, MD, LITESPARK-011 principal investigator and genitourinary medical oncologist at Memorial Sloan Kettering Cancer Center, said in a news release. “With this FDA approval of belzutifan plus lenvatinib, we have a new treatment option for patients who progress following treatment with anti-PD-1/PD-L1 therapy—an important development for patients and the physicians who care for them.”
References
- FDA approves belzutifan in combination with lenvatinib for advanced renal cell carcinoma with a clear cell component. News release. FDA. September 24, 2026. Accessed September 25, 2026.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-combination-lenvatinib-advanced-renal-cell-carcinoma-clear-cell-component - US FDA approves WELIREG (belzutifan) for certain previously treated adult patients with advanced renal cell carcinoma with a clear cell component (ccRCC). News release. Merck. September 25, 2026. Accessed September 25, 2026.
https://www.merck.com/news/u-s-fda-approves-welireg-belzutifan-plus-lenvima-lenvatinib-for-certain-previously-treated-adult-patients-with-advanced-renal-cell-carcinoma-with-a-clear-cell-component-ccrcc/
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