MRK
Padcev (enfortumab vedotin) + Keytruda (pembrolizumab)
FDA PDUFA Target Action Date · Merck & Co., Inc.
Monday, August 17, 2026
Approved July 15, 2026
approved Note: FDA Priority Review (Apr 20, 2026) for Keytruda + Padcev in cisplatin-ELIGIBLE perioperative MIBC (EV-304/KEYNOTE-B15). Distinct from the cisplatin-ineligible application.
Drug Information
- Application Type
- sBLA
- FDA Designations
- Priority Review
- Indication
- Perioperative (neoadjuvant then adjuvant) muscle-invasive bladder cancer, regardless of cisplatin eligibility
- Approved As
- LIPFENDRA →
Filing Details
- Company
- Merck & Co., Inc. →
- Stock Ticker
- MRK
- SEC CIK
- 0000310158
- Source
- Company PR →
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: 2026-06-29. Report an issue