Astellas Pharma Inc. is a Japanese multinational pharmaceutical company headquartered in Tokyo. Formed in 2005 through the merger of Yamanouchi Pharmaceutical and Fujisawa Pharmaceutical, the company discovers, develops, manufactures, and markets prescription medicines worldwide. Its research focuses on areas such as oncology, urology, immunology, neuroscience, ophthalmology, and rare diseases, with growing activity in advanced modalities including cell and gene therapies.
For the broader chemicals and life sciences ecosystem, Astellas integrates small‑molecule and biologics R&D with process chemistry, formulation development, and CMC disciplines, operating cGMP manufacturing and quality systems across Japan, the Americas, Europe, and Asia. The company participates in global supply chains for active pharmaceutical ingredients and drug products, and advances technologies such as antibody–drug conjugates and gene therapy manufacturing through internal capabilities and partnerships. Its operations emphasize regulatory compliance, pharmacovigilance, and product quality across the development-to-commercialization lifecycle.
Also known as Astellas.
CHMP recommends approval after KEYNOTE-B15 showed event-free survival, overall survival and pathologic complete response gains; European Commission decision expected Q4 2026.
FDA clears PD‑1 inhibitor plus antibody‑drug conjugate regimens with enfortumab vedotin as neoadjuvant and adjuvant therapy around cystectomy for adults with muscle‑invasive bladder cancer.
First PD‑1 inhibitor plus ADC approved in EU as neoadjuvant then adjuvant therapy for cisplatin‑ineligible resectable muscle‑invasive bladder cancer.
CHMP backed perioperative regimen for cisplatin‑ineligible resectable MIBC after Phase 3 KEYNOTE‑905 showed significant EFS, OS and pCR gains; EC decision due by Q3 2026; FDA cleared Nov 2025.
FDA granted priority review for two sBLAs after Phase 3 KEYNOTE‑B15 showed EFS and OS benefit; PDUFA Aug 17, 2026. If approved, first perioperative options for MIBC regardless of cisplatin eligibility.
KEYTRUDA and Padcev improve survival and response rates in MIBC patients, showing promise as perioperative treatment with consistent safety profiles.
FDA approves first PD-1 inhibitor plus ADC regimens for cisplatin-ineligible muscle-invasive bladder cancer, based on KEYNOTE-905 trial results showing significant EFS improvement.
