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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, backed by the phase 3 LITESPARK-011 trial, showed the combo cut the risk of disease progression by 26% versus the standard-of-care drug cabozantinib. It marks belzutifan's third approved indication in kidney cancer.
The FDA has approved belzutifan (Welireg, Merck) combined with lenvatinib (Lenvima, Eisai) for adults with advanced renal cell carcinoma with a clear cell component (ccRCC) who have previously received a PD-1 or PD-L1 inhibitor. This is belzutifan's third ccRCC indication, following earlier approvals as adjuvant therapy with pembrolizumab and as monotherapy after both immunotherapy and a VEGF TKI.
The approval is based on the phase 3 LITESPARK-011 trial, which enrolled 747 patients who had progressed on or after immunotherapy. Patients were randomized 1:1 to receive belzutifan plus lenvatinib or cabozantinib monotherapy. The combo demonstrated a meaningful improvement in progression-free survival and a higher response rate, though the overall survival benefit did not reach statistical significance.
By the Numbers:
Why it matters: For patients with advanced ccRCC who've exhausted immunotherapy options, this approval offers a more effective second-line treatment option — expanding the therapeutic toolkit in a cancer type where durable responses remain challenging.
