The U.S. Food and Drug Administration accepted a supplemental Biologics License Application for the perioperative combination of PADCEV (enfortumab vedotin‑ejfv) and Keytruda (pembrolizumab) in muscle‑invasive bladder cancer and granted the submission priority review status. The agency has set a target action date of August 17, 2026, which would accelerate the potential market launch of a therapy that could generate significant revenue for Pfizer’s oncology portfolio and strengthen its position in the competitive bladder‑cancer market.
The approval is based on data from the Phase 3 EV‑304 (KEYNOTE‑B15) trial, which demonstrated a 47% reduction in the risk of tumor recurrence, progression or death and a 35% reduction in the risk of death compared with standard neoadjuvant chemotherapy. The trial also reported a 55.8% pathological complete response rate versus 32.5% for chemotherapy alone, underscoring the combination’s superior efficacy in the perioperative setting.
Previously, the PADCEV‑Keytruda combination was approved only for cisplatin‑ineligible patients. The new submission seeks to expand the indication to all muscle‑invasive bladder cancer patients, regardless of cisplatin eligibility. This broadened patient population could increase the addressable market, enhance the product’s commercial appeal, and position the combination as the first perioperative treatment for this disease.
Moitreyee Chatterjee‑Kishore, PhD, MBA, Head of Oncology Development at 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 Lego, PhD, MBA, Chief Oncology Officer at Pfizer, noted the trial’s 47% reduction in recurrence, progression or death and a 35% reduction in death compared with standard neoadjuvant chemotherapy. Dr. Marjorie Green, senior vice president and head of oncology at Merck Research Laboratories, added, “Results from KEYNOTE‑B15 challenge long‑held expectations for patients with muscle‑invasive bladder cancer. Even with curative‑intent surgery and chemotherapy, patients still experience disease progression or limited survival. These data add to the growing body of evidence demonstrating that KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, have the potential to reshape how we approach treatment for these patients and improve outcomes for people facing this aggressive disease.”
The FDA’s priority‑review designation signals a strong likelihood of approval, which would give Pfizer and Astellas a first‑mover advantage in a market that is rapidly evolving with new agents and combinations. The expanded indication could unlock a larger patient cohort, potentially driving significant revenue growth for both companies and reinforcing Pfizer’s strategy to strengthen its oncology pipeline following the acquisition of Seagen. Astellas, for whom PADCEV is a key strategic brand, stands to benefit from increased market share and a broader therapeutic footprint.
The regulatory milestone marks a critical step toward making the PADCEV‑Keytruda combination a standard of care for muscle‑invasive bladder cancer patients, regardless of cisplatin eligibility. Approval would not only broaden the product’s commercial reach but also solidify Pfizer’s and Astellas’ positions in a competitive oncology landscape that is increasingly focused on perioperative, platinum‑free regimens.
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