News Releases

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

Month Year

Jun 23, 2022

Astellas Submits Fezolinetant New Drug Application to U.S. FDA
Jun 8, 2022

Astellas Celebrates the Opening of Its New Large-Scale Gene Therapy Manufacturing Facility in North Carolina
- Video 1
- Photos 1
May 31, 2022

Astellas and GO Therapeutics Enter into Strategic Research and License Agreement to Develop Novel Antibodies for Immuno-Oncology
- Photos 1
May 12, 2022

Astellas Highlights Data on Advanced and Rare Cancers during 2022 ASCO Annual Meeting and EHA 2022 Hybrid Congress
May 5, 2022

Astellas to Present 12-Week Data from Pivotal Phase 3 SKYLIGHT 1™ Trial of Fezolinetant in Oral Session at the American College of Obstetricians and Gynecologists Annual Meeting
Apr 25, 2022

Astellas Oncology Now Accepting Applications for Annual C3 Prize to Cultivate Innovation in Cancer Care Beyond Medicine
Apr 25, 2022

University of Tokyo, Astellas Enter Second Phase of Strategic Partnership for Co-creation of Innovative New Medicines and Medical Solutions
Apr 13, 2022

European Commission Approves PADCEV™ (enfortumab vedotin) for Locally Advanced or Metastatic Urothelial Cancer
Mar 14, 2022

Astellas Announces Topline 12-week Results from Phase 3 Study of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Women in Asia
Mar 7, 2022

Astellas Announces Topline Results from Long-Term Phase 3 Safety Study of Fezolinetant which Inform Future Regulatory Filings for the Treatment of Vasomotor Symptoms Associated with Menopause
Feb 28, 2022

Astellas and Seagen Announce CHMP Confirms Positive Opinion for PADCEV™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer
Feb 14, 2022

Astellas and Seagen Announce Initial Results of PADCEV® (enfortumab vedotin-ejfv) in Patients With Muscle-Invasive Bladder Cancer Not Eligible for Cisplatin Chemotherapy

- Late-breaking data from Cohort H of EV-103 trial to be presented at the 2022 ASCO Genitourinary Cancers Symposium -
Feb 7, 2022

Astellas Announces Positive Safety Data from the FORTIS Study of AT845 in Adults with Late-Onset Pompe Disease

- Data presented at the 18th Annual WORLDSymposiumTM 2022 -
Dec 17, 2021

Astellas and Seagen Receive Positive CHMP Opinion for PADCEV™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

- If approved, PADCEV would be the first medicine for patients in the EU who have received prior platinum-based chemotherapy and a PD-1/L1 inhibitor -
Dec 14, 2021

Astellas and MBC BioLabs Announce Future Innovator Prize Winners - Helping Biotech Start-ups Accelerate Early Research Efforts

- Vcreate and Weatherwax Biotechnologies win a year of access to life-science incubator in San Francisco, CA and to Astellas expertise to further their research -
Dec 1, 2021

Astellas and Dyno Therapeutics Announce Research Collaboration to Develop Next-Generation AAV Gene Therapy Vectors for Skeletal and Cardiac Muscle

- Dyno receives $18 million upfront and is eligible for milestone and royalty payments potentially exceeding $1.6 billion -
Dec 1, 2021

Astellas to Present Research on FLT3 Mutation-Positive Acute Myeloid Leukemia - from Diagnosis to Relapse - at 2021 American Society of Hematology Annual Meeting

- Four AML oral presentations are among highest number of Astellas-sponsored ASH abstracts to date
Nov 17, 2021

The Astellas Global Health Foundation provides $1.85 million in funding to five organizations focused on improving health and COVID-19 recovery efforts for more than four million people in low-income communities

New grants will support needed education, training and community resilience in five countries
- Photos 1
Nov 3, 2021

Astellas and LabCentral Announce Future Innovator Prize Winners - Helping Emerging Biotechs Accelerate Growth of Innovative Science

- Thymmune Therapeutics and M13 Therapeutics win a year of access to life-science incubator in Cambridge, MA and access to Astellas expertise to further their research -
Oct 12, 2021

Astellas and Seagen Complete Enrollment in EV-103 Trial Cohort K Combining PADCEV® (enfortumab vedotin-ejfv) with Pembrolizumab as First-Line Treatment for Advanced Urothelial Cancer
Sep 28, 2021

Astellas Recognized Consistently Among Top Companies for Working Parents

Astellas ranked again in Seramount's 100 Best Companies and Best Companies for Dads lists.
Sep 27, 2021

Japan's MHLW Approves PADCEV® (enfortumab vedotin) for Advanced Urothelial Cancer

- Enfortumab vedotin is the first and only antibody-drug conjugate (ADC) approved in Japan for patients with advanced urothelial cancer -
Sep 22, 2021

Astellas to Present Fezolinetant 12-Week Findings from Phase 3 SKYLIGHT 2™ Trial in Oral Session at The North American Menopause Society 2021 Annual Meeting

Astellas' investigational non-hormonal treatment demonstrates reduction in frequency and severity of moderate to severe vasomotor symptoms (VMS) associated with menopause
Sep 21, 2021

Astellas and MBC BioLabs Announce Future Innovator Prize 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 17, 2021

Astellas' and Pfizer's XTANDI® (enzalutamide) Reduced Risk of Death by 34% in Men with Metastatic Hormone-Sensitive Prostate Cancer in Phase 3 ARCHES Study

Late-breaking abstract to be presented September 18 during European Society for Medical Oncology Congress 2021
- Photos 1
Sep 14, 2021

Astellas Reports Update to September 1 Announcement on the ASPIRO Clinical Trial of AT132 in Patients with X-linked Myotubular Myopathy
Sep 1, 2021

Astellas Provides Update on ASPIRO Clinical Trial of AT132 in Patients with X-linked Myotubular Myopathy
Aug 19, 2021

Astellas Receives European Commission Approval for First-in-Class EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease

Roxadustat is the first orally administered hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) inhibitor available for adult patients with anemia associated with chronic kidney disease in Europe
Aug 18, 2021

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

Astellas' "Future Innovator Prize" sponsorship provides access to life-science incubator and in-house Astellas expertise for scientific entrepreneurs with cutting-edge ideas
Jul 20, 2021

U.S. Food and Drug Administration Expands Indication for PROGRAF® for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients

- PROGRAF Becomes First Immunosuppressive Drug Approved in the U.S. for People Receiving a Lung Transplant -
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
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

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