News Releases

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

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
Mar 26, 2021

Astellas Receives Positive CHMP Opinion for XTANDI™ (enzalutamide) for Patients with Metastatic Hormone-Sensitive Prostate Cancer

If approved by the European Commission, enzalutamide will be the only oral therapy for the treatment of metastatic hormone-sensitive prostate cancer in addition to non-metastatic and metastatic castration-resistant prostate cancer
Mar 26, 2021

European Medicines Agency Accepts Marketing Authorization Application for Enfortumab Vedotin

- Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial cancer -
Mar 24, 2021

Astellas Oncology Announces Grand Prize Winner of Fifth Annual C³ Prize® Challenge

- Three innovators awarded $200,000 in total grants and resources for their work to "Change Cancer Care" beyond medicine -
- Photos 1
Mar 11, 2021

Astellas Submits New Drug Application for Enfortumab Vedotin in Japan

Enfortumab vedotin to be reviewed by Ministry of Health, Labour and Welfare for patients with locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication

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