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News
The FDA has approved the combination of belzutifan (Welireg) and lenvatinib (Lenvima) for adults with advanced clear cell renal cell carcinoma (ccRCC) who've already received immunotherapy. The approval is backed by the phase 3 LITESPARK-011 trial, which showed a 26% improvement in progression-free survival over the current standard of care, cabozantinib. This marks a new second-line option for a tough-to-treat cancer.
The FDA has officially approved the combination of belzutifan (Welireg) and lenvatinib (Lenvima) for adult patients with advanced clear cell renal cell carcinoma (ccRCC) who have progressed on or after PD-1/PD-L1 inhibitor therapy. The decision was supported by data from the randomized, phase 3 LITESPARK-011 trial, which enrolled 747 patients and compared the combo against cabozantinib (Cabometyx) monotherapy.
The combination demonstrated meaningful improvements in both progression-free survival and objective response rate compared to cabozantinib, though the overall survival benefit did not reach statistical significance. The recommended dosing is 120 mg belzutifan plus 20 mg lenvatinib orally once daily until disease progression or unacceptable toxicity.
By the Numbers:
Why it matters: For patients with advanced ccRCC who've exhausted first-line immunotherapy, treatment options have been limited. This approval offers a new, more effective second-line regimen — though clinicians will need to weigh the meaningful efficacy gains against a notable toxicity burden.
