Highlights 

  • Pfizer and Astellas Pharma receive FDA approval for PADCEV + Keytruda combination in cisplatin-ineligible MIBC 
  • Approval is based on Phase 3 EV-303 (KEYNOTE-905) clinical trial results 
  • Treatment covers both neoadjuvant and adjuvant use around cystectomy 
  • Combination continues to expand its global approvals in urothelial cancer 
  • Keytruda developer Merck partnered with Seagen and Astellas prior to Pfizer's acquisition of Seagen 

Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. announced that the U.S.Food and Drug Administrationhas granted approval for PADCEV (enfortumab vedotin-ejfv) in combination with Merck’s Keytruda (pembrolizumab) or Keytruda QLEX. The therapy is now cleared for perioperative use in adults with muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin-based chemotherapy. 

The regimen is approved for use both before and after cystectomy—first as neoadjuvant therapy and then continued as an adjuvant treatment. This positions the combination as an important new option for a patient group with limited alternatives due to cisplatin ineligibility, which remains a challenge in bladder cancer management. 

The FDA decision is supported by data from the Phase 3 EV-303 (KEYNOTE-905) trial, which evaluated the benefit of the PADCEV + Keytruda combination around surgical intervention in MIBC patients.

Clinical Development Expands Across Additional Patient Groups

The companies noted that the same combination is under evaluation in another late-stage trial, EV-304 (KEYNOTE-B15), which is enrolling in cisplatin-eligible MIBC patients. If results are favorable, the therapy could potentially serve patients across both eligibility categories, further broadening its treatment footprint. 

PADCEV in combination with Keytruda is already approved in several markets—including the United States and Japan—for adults with locally advanced or metastatic urothelial cancer. In the European Union, it is cleared for patients with metastatic disease who are candidates for platinum-containing chemotherapy. PADCEV is also approved as a single agent for certain patients who previously received PD-1/PD-L1 therapy and chemotherapy. 

These approvals reflect a growing evidence base showing meaningful clinical benefit in urothelial cancer settings.

Partnership Background and Merck Collaboration

The Keytruda combination program originated from a collaboration between Seagen and Astellas, aimed at advancing ADC-plus-immunotherapy treatment options for bladder cancer. Merck (NYSE:MRK), the developer of Keytruda, joined the effort to evaluate the synergy between PADCEV and Pembrolizumab. 

Pfizer completed its acquisition of Seagen in December 2023, bringing the global oncology portfolio—including PADCEV—under Pfizer’s umbrella. The FDA approval strengthens Pfizer’s expanding presence in the antibody-drug conjugate market, an area of increasing interest due to its potential to combine targeted delivery with potent therapeutic activity. 

Conclusion 

The FDA's latest approval for Pfizer and Astellas marks a significant development for cisplatin-ineligible MIBC patients, offering a new perioperative therapeutic pathway backed by Phase 3 clinical evidence. As research continues across broader patient populations, PADCEV and Keytruda may establish a new treatment paradigm in both localized and advanced urothelial cancer. With ongoing trials and global regulatory momentum, the combination is positioned to remain an important component of the evolving bladder cancer landscape. 

Gilead Sciences’ shares closed at USD 25.04, marking a 2.62% increase from the prior session. 

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