TLDR
- Pfizer stock rises after FDA expands PADCEV use in bladder cancer treatment
- FDA clears PADCEV and Keytruda for use before and after bladder cancer surgery
- Phase 3 trial reports a 47% lower risk of recurrence, progression, or death
- PADCEV regimen cuts death risk by 35% versus standard chemotherapy treatment
- Approval creates the first platinum-free regimen for eligible adult MIBC patients
Pfizer Inc. (PFE) stock traded at $24.28, rising 0.12% after recovering from a sharp early decline. The modest gain followed FDA approval of an expanded PADCEV combination for muscle-invasive bladder cancer. The decision introduces the first approved platinum-free treatment for eligible adult patients before and after surgery.
FDA Expands PADCEV Combination Approval
The FDA approved PADCEV with Keytruda or Keytruda QLEX for adults with muscle-invasive bladder cancer. Doctors can now use the combination before surgery and continue treatment after surgery. The approval applies to patients regardless of their eligibility for cisplatin chemotherapy.
PADCEV targets Nectin-4, a protein commonly found on the surface of bladder cancer cells. Keytruda blocks the PD-1 pathway, which helps cancer cells avoid immune system attacks. Together, the medicines target cancer cells while strengthening the body’s immune response.
Pfizer develops PADCEV with Astellas Pharma, while Merck produces Keytruda and Keytruda QLEX. The companies previously secured approval for patients who could not receive cisplatin. The latest decision expands treatment access to a broader group of adult patients.
Phase 3 Trial Shows Survival Improvement
The FDA based its decision on findings from the Phase 3 EV-304 trial. Researchers compared PADCEV and pembrolizumab against gemcitabine and cisplatin chemotherapy. All patients received surgery after completing their assigned treatment before the operation.
The PADCEV combination reduced the risk of recurrence, progression, or death by 47%. After two years, 79.4% of combination patients remained event-free. By comparison, the chemotherapy group recorded an event-free rate of 66.2%.
The combination also reduced the risk of death by 35% compared with chemotherapy. Moreover, 55.8% of treated patients showed no remaining cancer during surgery. The chemotherapy group achieved a lower pathological complete response rate of 32.5%.
Approval Expands Pfizer’s Bladder Cancer Position
The treatment schedule included nine planned PADCEV cycles and 17 pembrolizumab cycles. Doctors divided those cycles between the periods before and after surgery. This approach targets visible tumors and remaining cancer cells throughout the treatment process.
Researchers found no new safety signals during the EV-304 clinical trial. Serious adverse events affected 75.7% of patients receiving the PADCEV combination. The chemotherapy group recorded serious adverse events among 67.2% of participating patients.
Muscle-invasive bladder cancer spreads into the bladder’s muscular wall and often requires major surgery. Doctors have used platinum chemotherapy before surgery as a standard treatment for suitable patients. The approval provides a non-platinum option with demonstrated event-free and overall survival benefits.
Get 3 Free Stock Ebooks
Discover top-performing stocks in AI, Crypto, and Technology with expert analysis.
- Top 10 AI Stocks - Leading AI companies
- Top 10 Crypto Stocks - Blockchain leaders
- Top 10 Tech Stocks - Tech giants
