# WELIREG (belzutifan) + LENVIMA (lenvatinib) PDUFA Event: Previously treated advanced renal cell carcinoma

Canonical URL: https://biopharmsignal.com/pdufa-calendar/MRK/welireg-lenvima-previously-treated-advanced-rcc

Ticker: MRK

Company: Merck

Event date: 2026-10-04

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: sNDA

FDA decisions expected. FDA assigned an October 4, 2026 PDUFA target action date to both supplemental applications for WELIREG plus LENVIMA.

## Event Timeline

### October 4, 2026 — FDA 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](https://www.merck.com/news/welireg-belzutifan-plus-lenvima-lenvatinib-reduced-the-risk-of-disease-progression-or-death-by-30-compared-to-cabozantinib-in-certain-previously-treated-patients-with-advanced-renal-ce/)

### February 28, 2026 — 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](https://www.merck.com/news/welireg-belzutifan-plus-lenvima-lenvatinib-reduced-the-risk-of-disease-progression-or-death-by-30-compared-to-cabozantinib-in-certain-previously-treated-patients-with-advanced-renal-ce/)

### October 28, 2025 — 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](https://www.merck.com/news/merck-and-eisai-announce-welireg-belzutifan-plus-lenvima-lenvatinib-met-primary-endpoint-of-progression-free-survival-pfs-in-certain-previously-treated-patients-with-advanced-renal-c/)

### February 25, 2021 — 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)](https://clinicaltrials.gov/study/NCT04586231)

## Related Pages

- MRK PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/MRK.md

- MRK company profile: https://biopharmsignal.com/company/MRK.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md