Astellas Pharma and Pfizer have secured a key regulatory milestone.

 

The two pharma powerhouses have announced that the US Food and Drug Administration (FDA) has accepted priority review for their bladder cancer treatment expansion.

 

The priority review is of perioperative PADCEV (enfortumab vedotin-ejfv) in combination with Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) for patients with muscle-invasive bladder cancer (MIBC).

 

A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline.

 

The push is backed by strong Phase 3 EV-304 (KEYNOTE-B15) data, presented at the 2026 ASCO Genitourinary Cancers Symposium. 

 

The study showed a 47% reduction in the risk of recurrence, progression, or death and a 35% reduction in risk of death compared with standard chemotherapy. The combination also achieved a 55.8% pathological complete response rate versus 32.5% with chemotherapy alone.

 

Moitreyee Chatterjee-Kishore, Head of Oncology Development, Astellas, said: “The data from the EV-304 trial take us another step closer to bringing perioperative enfortumab vedotin plus pembrolizumab to patients with muscle-invasive bladder cancer regardless of cisplatin eligibility, who still face a recurrence rate of more than fifty percent despite curative-intent surgery, highlighting the ongoing need for improved treatment strategies.”

 

Jeff Legos, Chief Oncology Officer, Pfizer, said: “For people with muscle-invasive bladder cancer, surgery is often just the beginning of a long and uncertain journey, with far too many patients seeing their cancer return. 

 

"If approved, perioperative PADCEV plus pembrolizumab could meaningfully change that experience, potentially helping patients reduce the risk of recurrence and live longer, regardless of whether they are eligible for cisplatin.”