WELIREG (belzutifan) + LENVIMA (lenvatinib)
Previously treated advanced renal cell carcinoma · Adults with advanced renal cell carcinoma with a clear cell component following a PD-1 or PD-L1 inhibitor
MRK · Merck
Full timeline
4 milestonesFDA decisions expected
FDA assigned an October 4, 2026 PDUFA target action date to both supplemental applications for WELIREG plus LENVIMA.
Merck — LITESPARK-011 results and PDUFA date↗FDA acceptance and detailed Phase 3 results were reported
Merck and Eisai said FDA accepted the two sNDAs. In LITESPARK-011, WELIREG plus LENVIMA reduced the risk of progression or death by 30% versus cabozantinib.
Merck — LITESPARK-011 results and FDA acceptance↗LITESPARK-011 met its progression-free survival endpoint
The Phase 3 study showed a statistically significant and clinically meaningful improvement in progression-free survival versus cabozantinib at the first interim analysis.
Merck — Positive topline LITESPARK-011 results↗Phase 3 LITESPARK-011 study started
The pivotal trial began evaluating belzutifan plus lenvatinib against cabozantinib in advanced clear-cell renal cell carcinoma after prior PD-1/PD-L1 therapy.
ClinicalTrials.gov — LITESPARK-011 study record (NCT04586231)↗Related News
No related news available.