# WELIREG (belzutifan) + KEYTRUDA (pembrolizumab) or KEYTRUDA QLEX PDUFA Event: Adjuvant treatment of clear cell renal cell carcinoma at increased risk of recurrence

Canonical URL: https://biopharmsignal.com/pdufa-calendar/MRK/welireg-keytruda-adjuvant-clear-cell-rcc

Ticker: MRK

Company: Merck

Event date: 2026-06-19

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-06-12

Application type: sNDA + sBLA

FDA approved WELIREG plus KEYTRUDA. FDA approved belzutifan with pembrolizumab or KEYTRUDA QLEX as adjuvant treatment for adults with clear cell renal cell c...

## Event Timeline

### June 12, 2026 — FDA approved WELIREG plus KEYTRUDA

FDA approved belzutifan with pembrolizumab or KEYTRUDA QLEX as adjuvant treatment for adults with clear cell renal cell carcinoma at increased risk of recurrence after surgery.

[FDA — WELIREG plus KEYTRUDA adjuvant RCC approval](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma)

### February 28, 2026 — FDA accepted the supplemental applications with Priority Review

FDA accepted the WELIREG sNDA and KEYTRUDA/KEYTRUDA QLEX sBLAs, assigned a June 19 action date, and Merck presented detailed LITESPARK-022 results showing a 28% reduction in recurrence or death.

[Merck — LITESPARK-022 results and FDA Priority Review](https://www.merck.com/news/keytruda-pembrolizumab-plus-welireg-belzutifan-given-as-adjuvant-therapy-reduced-the-risk-of-disease-recurrence-or-death-by-28-compared-to-keytruda-monotherapy-in-certain-patients-with/)

### January 2026 — LITESPARK-022 met its primary endpoint

The pivotal trial demonstrated a statistically significant improvement in disease-free survival for WELIREG plus KEYTRUDA compared with KEYTRUDA alone.

[Merck — LITESPARK-022 regulatory and clinical milestone summary](https://www.merck.com/news/merck-co-inc-rahway-n-j-usa-announces-first-quarter-2026-financial-results-highlights-significant-regulatory-approvals-and-clinical-milestones/)

### March 15, 2022 — Phase 3 LITESPARK-022 study started

The randomized trial began evaluating adjuvant belzutifan plus pembrolizumab after nephrectomy in patients with clear cell renal cell carcinoma.

[ClinicalTrials.gov — LITESPARK-022 study record (NCT05239728)](https://clinicaltrials.gov/study/NCT05239728)

## Regulatory Designations

- Priority Review FDA: [Merck — FDA acceptance, Priority Review and June 19 PDUFA date](https://www.merck.com/news/keytruda-pembrolizumab-plus-welireg-belzutifan-given-as-adjuvant-therapy-reduced-the-risk-of-disease-recurrence-or-death-by-28-compared-to-keytruda-monotherapy-in-certain-patients-with/)

## 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