# KEYTRUDA (pembrolizumab) or KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) + PADCEV (enfortumab vedotin-ejfv) PDUFA Event: Perioperative treatment of muscle-invasive bladder cancer

Canonical URL: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-padcev-muscle-invasive-bladder-cancer

Ticker: MRK

Company: Merck

Event date: 2026-08-17

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-07-10

Application type: sBLA

Original PDUFA date superseded by early approval. FDA had assigned August 17 as the target action date for the supplemental applications. The agency approved...

## Event Timeline

### August 17, 2026 — Original PDUFA date superseded by early approval

FDA had assigned August 17 as the target action date for the supplemental applications. The agency approved the expanded perioperative indication on July 10, more than a month before the goal date.

[Merck — Priority Review and original PDUFA date](https://www.merck.com/news/fda-grants-priority-review-for-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-padcev-enfortumab-vedotin-ejfv-for-cisplati/)

### July 10, 2026 — FDA approved perioperative treatment regardless of cisplatin eligibility

FDA approved KEYTRUDA or KEYTRUDA QLEX, each with PADCEV, as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with MIBC. The decision expanded the prior cisplatin-ineligible indication to all patients with MIBC who are candidates for cystectomy.

[FDA — Approval of pembrolizumab and enfortumab vedotin for MIBC](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin)

### April 20, 2026 — FDA granted Priority Review

FDA granted Priority Review to the KEYTRUDA and KEYTRUDA QLEX supplemental applications, each in combination with PADCEV, for cisplatin-eligible patients with MIBC and assigned the August 17 action date.

[Merck — FDA granted Priority Review](https://www.merck.com/news/fda-grants-priority-review-for-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-padcev-enfortumab-vedotin-ejfv-for-cisplati/)

### February 27, 2026 — Detailed KEYNOTE-B15 results were presented

In cisplatin-eligible MIBC, perioperative KEYTRUDA plus PADCEV reduced the risk of recurrence, progression or death by 47% and the risk of death by 35% versus neoadjuvant gemcitabine and cisplatin followed by surgery. The Phase 3 trial also showed a higher pathological complete response rate.

[Merck — Detailed Phase 3 KEYNOTE-B15 results](https://www.merck.com/news/keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-reduced-risk-of-event-free-survival-events-by-47-and-risk-of-death-by-35-for-cisplatin-eligible-patients-with-muscle-invasive/)

### December 17, 2025 — KEYNOTE-B15 reported positive topline results

The Phase 3 KEYNOTE-B15/EV-304 trial met its primary event-free survival endpoint and key secondary overall survival and pathological complete response endpoints in cisplatin-eligible patients with MIBC.

[Pfizer and Astellas — Positive KEYNOTE-B15 topline results](https://www.pfizer.com/print/pdf/node/562724)

### November 21, 2025 — FDA approved the regimen for cisplatin-ineligible MIBC

FDA approved perioperative PADCEV with KEYTRUDA or KEYTRUDA QLEX for adults with MIBC who were ineligible for cisplatin-containing chemotherapy. The later KEYNOTE-B15 applications sought to extend use to cisplatin-eligible patients.

[Pfizer and Astellas — Prior approval in cisplatin-ineligible MIBC](https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-padcevr-plus-keytrudar-certain-patients)

### January 7, 2021 — KEYNOTE-B15 was registered

The randomized, open-label Phase 3 trial was registered to compare perioperative enfortumab vedotin plus pembrolizumab with neoadjuvant gemcitabine and cisplatin in cisplatin-eligible patients with MIBC undergoing radical cystectomy.

[ClinicalTrials.gov — KEYNOTE-B15/EV-304 study record](https://clinicaltrials.gov/study/NCT04700124)

## Regulatory Designations

- Priority Review FDA: [Merck — FDA Priority Review and August 17 PDUFA date](https://www.merck.com/news/fda-grants-priority-review-for-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-padcev-enfortumab-vedotin-ejfv-for-cisplati/)

## 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