Astellas Pharma Announces FDDA Priority Review for Padcev-Keytruda Combination Therapy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 21 2025
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FDA Review Acceptance: Astellas Pharma's supplemental Biologics License Application for PADCEV in combination with KEYTRUDA has been accepted for priority review by the FDA.
Target Action Date: The FDA has set a target action date of April 7, 2026, under the Prescription Drug User Fee Act for this application.
Treatment Indication: The application is for a neoadjuvant treatment followed by adjuvant treatment for patients with muscle-invasive bladder cancer who cannot receive cisplatin-containing chemotherapy.
Combination Therapy: The proposed treatment involves using PADCEV and KEYTRUDA together to improve outcomes for eligible patients post-radical cystectomy.
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.
