Welireg (belzutifan) + Keytruda (pembrolizumab)
FDA PDUFA Target Action Date · Merck & Co., Inc.
Note: Approved 2026-06-12 (7 days early): KEYTRUDA (SUPPL-192, BLA125514) and KEYTRUDA QLEX, each with WELIREG (SUPPL-15, NDA215383), for adjuvant treatment of certain patients with clear cell RCC after nephrectomy, based on LITESPARK-022. Corrected 2026-10-06 from primary source: earlier auto-resolutions named KEYTRUDA QLEX and then a KEYTRUDA supplement dated 2026-06-24 (SUPPL-187, a different decision) because the old matcher took the approval closest in date and let a combination backbone settle the entry. Source: https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-welireg-belzutifan-for-adjuvant-treatment-of-certain-patients/
Drug Information
- Application Type
- sNDA + sBLA
- FDA Designations
- Priority Review
- Indication
- Adjuvant clear cell renal cell carcinoma (ccRCC) at increased risk of recurrence
- Approved As
- Welireg (belzutifan) + Keytruda (pembrolizumab)
Filing Details
- Company
- Merck & Co., Inc. →
- Stock Ticker
- MRK
- SEC CIK
- 0000310158
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue