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The EU's drug advisory committee has recommended approving belzutifan plus lenvatinib for advanced clear cell kidney cancer after prior immunotherapy — a combination already cleared by the FDA in September 2026. The recommendation is based on the phase 3 LITESPARK-011 trial, which showed the combo cut the risk of disease progression by 26% versus cabozantinib. A final European Commission decision is expected within two months.
Europe is one step closer to a new second-line treatment option for advanced clear cell renal cell carcinoma (ccRCC). The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of belzutifan (Welireg) plus lenvatinib (Lenvima) for adult patients whose disease has progressed after PD-1 or PD-L1 immunotherapy. The European Commission is expected to make a final marketing authorization decision within two months.
The recommendation follows the FDA's September 2026 approval of the same combination, both grounded in data from the phase 3 LITESPARK-011 trial. The study enrolled 747 patients with advanced ccRCC who had progressed after prior immunotherapy, randomizing them to belzutifan plus lenvatinib or cabozantinib. The combo significantly improved progression-free survival and response rates, though overall survival did not cross the prespecified statistical threshold.
By the Numbers:
Why it matters: Patients with advanced ccRCC have limited options after immunotherapy fails. This first-of-its-kind HIF-2α inhibitor plus TKI combination offers a meaningful PFS benefit and substantially higher response rates, potentially reshaping second-line treatment standards across Europe.
