News Releases

Click here to access press releases from Astellas Pharma Inc. located in Tokyo, Japan.

Month Year

Jul 9, 2021

U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer

- Regular Approval Based on Overall Survival Results from Confirmatory EV-301 Trial -
- Photos 2
Jun 25, 2021

Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease
Jun 8, 2021

New Research Reflects Astellas' Commitment to Acute Myeloid Leukemia at EHA 2021 Virtual Congress

Eight abstracts cover FLT3 mutation-positive AML, patient treatment preferences and utilization in hard-to-treat blood cancer
May 19, 2021

Astellas and Seagen Announce Updated Results from Two Trials of PADCEV® (enfortumab vedotin-ejfv) in Patients with Locally Advanced or Metastatic Urothelial Cancer Not Eligible for Cisplatin Chemotherapy

- Durable Responses Observed in Second Cohort of Patients in Pivotal EV-201 Trial of PADCEV and in Initial First-Line Cohort of the EV-103 Trial Evaluating PADCEV in Combination with KEYTRUDA® (pembrolizumab) -
May 17, 2021

Astellas to Present Data from Expanding Oncology Portfolio During the 2021 ASCO Annual Meeting

Astellas' ambitious innovation and committed collaboration support new research on investigational and approved therapies in hard-to-treat cancers
May 13, 2021

Japan's Ministry of Health, Labour and Welfare Grants Priority Review for Enfortumab Vedotin New Drug Application

NDA, submitted in March, is for locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication
May 4, 2021

Astellas' XTANDI™ (enzalutamide) Approved by European Commission for Men with Metastatic Hormone-Sensitive Prostate Cancer

Enzalutamide is now the only oral therapy approved by the European Commission to treat three distinct types of advanced prostate cancer
Apr 19, 2021

Astellas and Seagen Announce U.S. FDA Acceptance of Two Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

- Priority Review Granted with Action Date of August 17 -
Mar 29, 2021

Astellas' XOSPATA® (gilteritinib) Meets Overall Survival Endpoint in COMMODORE Trial of Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

- Confirmatory Phase 3 trial in China, other countries stopped early due to positive results at planned interim analysis -
Mar 26, 2021

Astellas Garners New Indication & New Product Formulation Approvals From U.S. FDA for Children with Neurogenic Detrusor Overactivity (NDO)

Myrbetriq® (Mirabegron Extended-Release Tablets) Approved for Pediatric Patients with NDO Aged Three Years and Older Weighing 35 kg or More

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