The panel discussed the risk-benefit profile of the Galleri multicancer early detection test, which was evaluated in the NHS-Galleri and PATHFINDER 2 studies.
News|Articles|September 24, 2026
Belzutifan Combo Receives FDA Approval in Advanced Clear Cell RCC
Author(s)Roman Fabbricatore
Fact checked by: Russ Conroy
Data from the phase 3 LITESPARK-011 trial support the FDA approval of belzutifan plus lenvatinib for adults with advanced clear cell renal cell carcinoma.
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The FDA has approved belzutifan (Welireg) in combination with lenvatinib (Lenvima) for the treatment of adult patients with advanced clear cell renal cell carcinoma (ccRCC) following progression on a PD-1 or PD-L1 inhibitor, according to a news release from the agency.
What were the data that supported the belzutifan approval?
Supporting the approval of belzutifan/lenvatinib in this PD-1/PD-L1–refractory group were data from the
Therein, the median progression-free survival (PFS) per blinded independent central review was 14.6 months (95% CI, 11.1-16.6) with belzutifan/lenvatinib vs 10.6 months (95% CI, 9.2-11.1) with cabozantinib; the HR for PFS was 0.74 (95% CI, 0.61-0.89; P = 0.00095). Moreover, a final analysis for overall survival (OS) revealed respective values of 33.7 months (95% CI: 29.0-46.9) vs 28.6 months (95% CI: 24.1-31.4) in each arm (HR, 0.85; 95% CI: 0.70-1.03). Moreover, the objective response rate (ORR) was 53% (95% CI, 47%-58%) vs 40% (95% CI, 35%-45%) in each arm (P = 0.0002).
What is the recommended dosage of the combination?
The recommended dosage for the combination is 20 mg of lenvatinib and 120 mg of belzutifan taken once daily in the absence of disease progression or unacceptable toxicity.
Prescribing information for belzutifan includes boxed warnings for embryo-fetal toxicity, in addition to warnings and precautions for anemia and hypoxia. The lenvatinib prescribing information includes warnings and precautions for hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, renal failure or impairment, proteinuria, diarrhea, fistula formation, and gastrointestinal perforation, among other conditions. Collectively, the combination includes warnings and precautions for cardiac dysfunction.
Reference
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 24, 2026. https://tinyurl.com/ynx76c3x
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