MRK

Padcev (enfortumab vedotin) + Keytruda (pembrolizumab)

FDA PDUFA Target Action Date · Merck & Co., Inc.

Monday, August 17, 2026

40 days away

Drug Information

Drug Name: Padcev (enfortumab vedotin) + Keytruda (pembrolizumab) (CT.gov)
Application Type: sBLA
FDA Designations: Priority Review
Indication: Perioperative muscle-invasive bladder cancer (cisplatin-eligible)

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