Astellas and Pfizer Submit New Drug Application for PADCEV
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 20 2026
0mins
Source: Newsfilter
- FDA Priority Review: The U.S. FDA has accepted the supplemental Biologics License Application for PADCEV™ (enfortumab vedotin-ejfv) submitted by Astellas and Pfizer, aiming to expand its indication for muscle-invasive bladder cancer (MIBC) patients, which, if approved, would mark the first perioperative treatment not limited by cisplatin eligibility, potentially transforming the standard of care.
- Clinical Trial Data Support: Data from the EV-304 clinical trial indicate that perioperative treatment with enfortumab vedotin and pembrolizumab reduces the risk of tumor recurrence, progression, or death by 47%, and lowers the risk of death by 35%, providing robust evidence for improving MIBC patient outcomes.
- Significant Market Potential: With over 614,000 new bladder cancer cases diagnosed globally each year, of which approximately 30% are MIBC patients, and with 50% facing recurrence despite surgery, the introduction of this new therapy addresses the urgent demand for effective treatment options in the market.
- Deepening Strategic Collaboration: This application aligns with Astellas' investment in an innovation center in the Asia-Pacific region, demonstrating the company's commitment to the MIBC treatment space and aiming to capture growth opportunities in this high-demand market through ongoing R&D investments.
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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: 25.950
Low
24.00
Averages
28.56
High
35.00
Current: 25.950
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, and others. Its PF-08653944 is an ultra-long-acting fully biased GLP-1 receptor agonist.
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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