News Releases

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

Month Year

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
Feb 19, 2021

Astellas Announces Positive Topline Results from Two Phase 3 Pivotal Global Trials of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Postmenopausal Women
Feb 18, 2021

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

- Submissions will be Reviewed Under Real-Time Oncology Review Based on Clinical Trials EV-301 and Cohort 2 of EV-201 -
Feb 12, 2021

Astellas and Seagen Announce Presentation of Results from PADCEV® (enfortumab vedotin-ejfv) Pivotal Trial in Patients with Previously Treated Advanced Urothelial Cancer Who Were Ineligible for Cisplatin Chemotherapy

- Durable Tumor Responses Experienced Among Patients Previously Treated with Immunotherapy in Second Cohort of EV-201 Trial -
Feb 12, 2021

Astellas and Seagen Announce Phase 3 Trial Results Demonstrating Survival Advantage of PADCEV® (enfortumab vedotin-ejfv) in Patients with Previously Treated Advanced Urothelial Cancer

- Findings from the EV-301 Trial Showed Significant Improvements in Overall Survival and Progression-Free Survival Compared to Chemotherapy -
Feb 4, 2021

Astellas expands Top Management, names Percival Barretto-Ko as Chief Business Officer; Yoshitsugu Shitaka as Chief Scientific Officer

Oncology head Mark Reisenauer named Astellas US President; Masahide Goto named President at Astellas Institute for Regenerative Medicine
Feb 3, 2021

Astellas' XOSPATA® (gilteritinib) Receives Conditional Approval by China's National Medical Products Administration for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

- Accelerated approval follows priority review designation and inclusion in overseas new drugs urgently needed in clinical settings
Jan 28, 2021

Astellas Achieves 100% Score on Corporate Equality Index for Seventh Consecutive Year
Jan 6, 2021

FDA Accepts for Priority Review the New Drug Application for mirabegron for Oral Suspension and Supplemental New Drug Application for Myrbetriq® (mirabegron) Tablets in Pediatric Patients
Dec 21, 2020

Astellas Reports XOSPATA® (gilteritinib) in Combination with Azacitidine Did Not Meet Endpoint of Overall Survival in Newly Diagnosed FLT3 Mutation-Positive Acute Myeloid Leukemia Patients Ineligible for Intensive Induction Chemotherapy
Dec 14, 2020

Astellas and MBC BioLabs Announce Winners of Golden Ticket Competition to Support Biotech Start-ups Accelerate Early Drug Discovery and Innovation

Sponsorship provides a year of access to MBC BioLabs' life-science incubators and in-house Astellas expertise
Nov 27, 2020

Astellas Receives Approval of EVRENZO® (roxadustat) in Japan for the Treatment of Anemia of Chronic Kidney Disease in Adult Patients Not on Dialysis

Approval by MHLW provides new HIF-PH inhibitor treatment option for healthcare providers and adult patients with anemia of CKD not on dialysis
Nov 16, 2020

Astellas to Present New Data on Gilteritinib in FLT3 Mutation-Positive Acute Myeloid Leukemia at the 2020 American Society of Hematology Annual Meeting

Includes five oral presentations that collectively explore the use of gilteritinib across the FLT3mut+ AML care continuum
Nov 6, 2020

XTANDI® (enzalutamide soft capsules) Approved by China NMPA for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer

Enzalutamide is now NMPA-approved for both non-metastatic and metastatic castration-resistant prostate cancer
Oct 28, 2020

Astellas Receives U.S. FDA Fast Track Designation for ASP5354, an Investigational Near-Infrared Fluorescence Imaging Agent
- Photos 1
Oct 20, 2020

U.S. FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies
Oct 19, 2020

New Roxadustat Data in Anemia of Chronic Kidney Disease to be Released at ASN Kidney Week 2020 Reimagined

42 abstracts featuring additional insights into roxadustat and anemia of chronic kidney disease to be presented
Oct 12, 2020

Astellas and Seagen Announce Positive Topline Results from Second Cohort of Patients in Phase 2 Pivotal Trial of PADCEV® (enfortumab vedotin-ejfv) in Advanced Urothelial Cancer

- Durable Responses Observed in Patients Who Had Previously Received Immunotherapy but Were Ineligible for Cisplatin in Locally Advanced or Metastatic Setting -
Oct 8, 2020

Astellas and LabCentral Announce Golden Ticket Winners - Helping Emerging Biotechs Accelerate Growth of Innovative Science

- AXONIS Therapeutics, Inc. and Tenza win a year of access to life-science incubator in Cambridge, MA and access to Astellas expertise to further their research -
Oct 1, 2020

Astellas Celebrates First-Ever Virtual Day of Service to Help Non-Profit Organizations Respond to Local Community Needs

- 11th Annual Changing Tomorrow Day Enables Employees to Support Frontline Workers in Hospitals, Homeless and Hospitalized Veterans and Others in Need -
- Photos 1
Sep 29, 2020

Astellas and MBC BioLabs Announce Golden Ticket Competition to Help Biotech Start-ups Accelerate Early Drug Discovery and Research Efforts

Sponsorship provides a year of access to MBC BioLabs' life-science incubators and in-house Astellas expertise for scientific innovators
Sep 28, 2020

Astellas' Real-World Evidence Studies Provide Further Insight into Negative Impacts of Vasomotor Symptoms (VMS) Associated with Menopause

New findings to be presented at The North American Menopause Society (NAMS) 2020 Virtual Annual Meeting
Sep 23, 2020

Astellas Establishes Global Patient Centricity Leadership Structure to Incorporate Patient Perspectives Across Research and Development Continuum
- Photos 1
Sep 18, 2020

Astellas and Seattle Genetics Announce PADCEV® (enfortumab vedotin-ejfv) Significantly Improved Overall Survival in Phase 3 Trial in Previously Treated Locally Advanced or Metastatic Urothelial Cancer

- Trial Stopped Early Due to Positive Results at Planned Interim Analysis -
Sep 15, 2020

Astellas Ranks Among Top Companies for Working Parents
Sep 1, 2020

The Astellas Global Health Foundation Provides $2 Million In COVID-19 Relief To Six Organizations Serving More Than 725,000 Lives In Vulnerable Communities In Seven Countries

Recent grants and redirected funding help to respond to the COVID-19 pandemic by improving healthcare infrastructure, training and education in low-income countries
Aug 4, 2020

Astellas Oncology Opens Annual C3 Prize® Call for Entries to Award the Best Innovations in Cancer Care Beyond Medicine

-Tackling everyday challenges in cancer care, apply by September 28, 2020-
Jul 23, 2020

Astellas Partners with LabCentral to Help Emerging Biotechs Accelerate Preclinical Scientific Research

Astellas "Golden Ticket" sponsorship provides access to life-science incubator and in-house Astellas expertise for scientific entrepreneurs with cutting-edge ideas
Jul 22, 2020

Astellas is Awarded Grant from the U.S. National Institutes of Health (NIH) to Fund Early Clinical Studies of ASP8062 to Investigate Potential Novel Therapeutic Approach to Address the Opioid Crisis
Jun 8, 2020

Roxadustat Demonstrates Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Adult Patients with Chronic Kidney Disease

- Study meets primary endpoint demonstrating non-inferiority of roxadustat to darbepoetin in correction and maintenance of hemoglobin levels
May 29, 2020

Final PROSPER Results Show XTANDI® (enzalutamide) Significantly Extends Overall Survival in Men with Non-Metastatic Castration-Resistant Prostate Cancer

Data simultaneously published in the New England Journal of Medicine and presented during the virtual scientific program of the 2020 ASCO Annual Meeting
May 29, 2020

XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis

XTANDI is now MHLW-approved for both metastatic hormone-sensitive prostate cancer and castration-resistant prostate cancer in Japan
May 27, 2020

FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients
May 20, 2020

European Medicines Agency Accepts Astellas' Marketing Authorization Application for Roxadustat

Submission for the treatment of anemia in adult patients with chronic kidney disease
Apr 30, 2020

Astellas Pharma Support Solutions Help to Address Evolving Patient Needs During COVID-19
Apr 9, 2020

Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration
Feb 19, 2020

Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer

- Breakthrough Therapy Designation Based on Initial Results from Phase 1b/2 EV-103 Clinical Trial -
Feb 11, 2020

XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC
Feb 10, 2020

Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as Investigational First-Line Treatment for Advanced Bladder Cancer

- After Median Follow-Up of 11.5 Months, 73 Percent of Patients Had Confirmed Tumor Response with Majority of Responses Still Ongoing; No New Safety Signals Observed for the Combination - - Findings To Be Presented During an Oral Session at the 2020 Genitourinary Cancers Symposium -
Feb 10, 2020

Astellas Global Health Foundation and AMPATH Announce a Three-Year $1.35 Million Grant to Aid Mental Health Programming in Western Kenya

- New Funding will Address Disparities in Mental Health Diagnosis and Treatment for 400,000 People in Need -
- Photos 1
Jan 29, 2020

Astellas Submits Supplemental New Drug Application for Approval of Evrenzo® (roxadustat) for the Treatment of Anemia Associated with Chronic Kidney Disease in Non-Dialysis Dependent Patients in Japan

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