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

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

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

- Priority Review Granted with Action Date of August 17 -

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Enzalutamide is now NMPA-approved for both non-metastatic and metastatic castration-resistant prostate cancer

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

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

- 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 -

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

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

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

- Trial Stopped Early Due to Positive Results at Planned Interim Analysis -

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

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

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

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

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

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

Submission for the treatment of anemia in adult patients with chronic kidney disease

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

- 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 -

- New Funding will Address Disparities in Mental Health Diagnosis and Treatment for 400,000 People in Need -