Pfizer: FDA Approves PADCEV and Keytruda Combination for Patients with Muscle-Invasive Bladder Cancer Who Cannot Receive Cisplatin
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 22 2025
0mins
Source: NASDAQ.COM
FDA Approval: The FDA has approved PADCEV (enfortumab vedotin-ejfv) in combination with Keytruda (pembrolizumab) for neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer (MIBC) in patients ineligible for cisplatin chemotherapy.
Clinical Trials: The approval is based on the Phase 3 EV-303 clinical trial, and PADCEV plus pembrolizumab is also being studied in cisplatin-eligible MIBC patients in the EV-304 trial.
Global Approvals: PADCEV plus pembrolizumab is approved for locally advanced or metastatic urothelial cancer (la/mUC) in multiple countries, with specific approvals in the EU for patients eligible for platinum chemotherapy.
Collaboration and Acquisition: Seagen and Astellas have a collaboration with Merck to evaluate PADCEV and Keytruda in MIBC patients, and Pfizer completed its acquisition of Seagen in December 2023.
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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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