WS News
13 Jul 2026, 17:28
Pfizer (PFE) Stock Rises After FDA Expands PADCEV Plus Keytruda Approval for Muscle-Invasive Bladder Cancer
Pfizer (NYSE: PFE) shares gained about 1.1% after the U.S. Food and Drug Administration approved PADCEV in combination with Keytruda as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility.
The expanded approval marks the first platinum-free treatment regimen approved for MIBC across all eligible patient groups, potentially establishing a new standard of care in earlier-stage bladder cancer.
The decision was supported by results from the Phase 3 EV-304 (KEYNOTE-B15) trial, in which PADCEV plus Keytruda demonstrated significant improvements over standard chemotherapy. The combination reduced the risk of tumor recurrence, progression, or death by 47%, lowered the risk of death by 35%, and achieved a pathological complete response rate of 55.8%, compared with 32.5% for standard chemotherapy.
The approval further expands the commercial opportunity for PADCEV, which Pfizer co-develops with Astellas, following its success in advanced bladder cancer. Investors also view the label expansion as strengthening Pfizer’s oncology portfolio by extending the therapy into an earlier-stage, potentially curative treatment setting.
Key factors supporting the stock include:
* The FDA approved PADCEV plus Keytruda for muscle-invasive bladder cancer regardless of cisplatin eligibility.
* The regimen became the first platinum-free treatment approved for this patient population.
* Phase 3 data showed a 47% reduction in the risk of recurrence, progression, or death and a 35% reduction in mortality versus standard chemotherapy.
* The expanded indication broadens PADCEV’s commercial potential and reinforces Pfizer’s long-term oncology growth strategy.
The regulatory approval improved investor sentiment, helping Pfizer shares move higher during the trading session.
Pfizer (NYSE: PFE) shares gained about 1.1% after the U.S. Food and Drug Administration approved PADCEV in combination with Keytruda as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility.
The expanded approval marks the first platinum-free treatment regimen approved for MIBC across all eligible patient groups, potentially establishing a new standard of care in earlier-stage bladder cancer.
The decision was supported by results from the Phase 3 EV-304 (KEYNOTE-B15) trial, in which PADCEV plus Keytruda demonstrated significant improvements over standard chemotherapy. The combination reduced the risk of tumor recurrence, progression, or death by 47%, lowered the risk of death by 35%, and achieved a pathological complete response rate of 55.8%, compared with 32.5% for standard chemotherapy.
The approval further expands the commercial opportunity for PADCEV, which Pfizer co-develops with Astellas, following its success in advanced bladder cancer. Investors also view the label expansion as strengthening Pfizer’s oncology portfolio by extending the therapy into an earlier-stage, potentially curative treatment setting.
Key factors supporting the stock include:
* The FDA approved PADCEV plus Keytruda for muscle-invasive bladder cancer regardless of cisplatin eligibility.
* The regimen became the first platinum-free treatment approved for this patient population.
* Phase 3 data showed a 47% reduction in the risk of recurrence, progression, or death and a 35% reduction in mortality versus standard chemotherapy.
* The expanded indication broadens PADCEV’s commercial potential and reinforces Pfizer’s long-term oncology growth strategy.
The regulatory approval improved investor sentiment, helping Pfizer shares move higher during the trading session.