FDA Grants Approval for PADCEV® in Combination with Keytruda® for Specific Bladder Cancer Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 21 2025
0mins
Should l Buy PFE?
Source: Newsfilter
FDA Approval: The FDA has approved PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as the first perioperative treatment for muscle-invasive bladder cancer (MIBC) patients who are ineligible for cisplatin, showing significant survival benefits over surgery alone.
Clinical Trial Results: The approval is based on the Phase 3 EV-303 trial, which demonstrated a 60% reduction in the risk of disease recurrence and a 50% reduction in the risk of death compared to surgery alone, with a two-year survival probability of 79.7% for the combination therapy.
Unmet Medical Need: This treatment addresses a critical gap for MIBC patients, as many are ineligible for cisplatin and face limited options, with half experiencing cancer recurrence post-surgery.
Safety Profile: The safety results were consistent with previous studies, with common adverse reactions including increased glucose levels, peripheral neuropathy, and skin reactions, necessitating close monitoring during treatment.
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Analyst Views on PFE
Wall Street analysts forecast PFE stock price to rise
16 Analyst Rating
5 Buy
11 Hold
0 Sell
Moderate Buy
Current: 27.370
Low
24.00
Averages
28.56
High
35.00
Current: 27.370
Low
24.00
Averages
28.56
High
35.00
About PFE
Pfizer Inc. is a research-based, global biopharmaceutical company. The Company is engaged in the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide. Its Biopharma segment includes the Pfizer U.S. Commercial Division, and the Pfizer International Commercial Division. Its product categories include oncology, primary care and specialty care. Its oncology products include Ibrance, Xtandi, Padcev, Adcetris, Inlyta, Lorbrena, Bosulif, Tukysa, Braftovi, Mektovi, Orgovyx, Elrexfio, Tivdak and Talzenna. Its primary care products include Eliquis, Nurtec ODT/Vydura, Zavzpret, the Prevnar family, Comirnaty, Abrysvo, FSME/IMMUN-TicoVac, Nimenrix, Trumenba, and Paxlovid. Its specialty care products include Xeljanz, Enbrel (outside the United States and Canada), Inflectra, Abrilada, Cibinqo, Litfulo, Eucrisa, Velsipity, the Vyndaqel family, Genotropin, BeneFIX, Xyntha, Somavert, Ngenla, Hympavzi, Sulperazon, Zavicefta, Octagam and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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