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Astellas is committed to providing timely and accurate information about our business, science and products. This section offers global resources for investors, journalists and media professionals. News and resources from our local affiliates can be viewed in the Local news section. If you are not an investor or journalist, click here.

Month Year

Sep 24, 2024

Astellas Receives Approval from the European Commission for VYLOY^TM (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer

- Zolbetuximab is currently the first and only therapy approved in the European Union to target claudin 18.2, a biomarker positively expressed by 38% of patients with advanced gastric cancer1,2 -

TOKYO, 20 September, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Commission (EC) has approved VYLOYTM (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients...

Read more about Astellas Receives Approval from the European Commission for VYLOY^TM (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer
Sep 24, 2024

Japan’s Ministry of Health, Labour and Welfare Approves PADCEV^TM(enfortumab vedotin) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Radically Unresectable Urothelial Carcinoma

- Approval based on the EV-302 trial where the treatment combination nearly doubled median overall survival and significantly extended progression free survival compared to platinum-containing chemotherapy, the current standard of care for first-line treatment of radically unresectable urothelial carcinoma1 -

TOKYO, September 24, 2024 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved PADCEVTM (enfortumab vedotin [genetical recombination]) with...

Read more about Japan’s Ministry of Health, Labour and Welfare Approves PADCEV^TM(enfortumab vedotin) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Radically Unresectable Urothelial Carcinoma
Sep 18, 2024

Astellas Announces FDA Listing of DIGITIVA^TM for the Management of Heart Failure

- New digital health solution for heart failure management puts patients at the center of their care by providing ability for at-home disease monitoring -

TOKYO, September 18, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that DIGITIVA™, a non-invasive digital health solution for heart failure management, has been listed with...

Read more about Astellas Announces FDA Listing of DIGITIVA^TM for the Management of Heart Failure
Sep 11, 2024

Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024

- Eight abstracts, including two oral presentations, feature new clinical data from Astellas’ oncology portfolio and two lead pipeline programs across a broad range of cancer types -

TOKYO, September 11, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society...

Read more about Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024
Sep 4, 2024

Astellas to Present VEOZAH^TM (fezolinetant) Data at 2024 Annual Meeting of The Menopause Society

- Pooled analyses from two SKYLIGHT™ studies highlight impact on sleep disturbance and impairment, relationship between improvements in the frequency or severity of hot flashes and mood -

TOKYO, September 4, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced that VEOZAH™ (fezolinetant), its first-in-class treatment for moderate to severe vasomotor symptoms...

Read more about Astellas to Present VEOZAH^TM (fezolinetant) Data at 2024 Annual Meeting of The Menopause Society
Sep 3, 2024

Notice Regarding Issuance of Unsecured Bonds

TOKYO, September 3, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) successfully priced a dual-tranche of series 5th and 6th JPY denominated unsecured bonds (”the Bonds”) as below. The issuance of the Bonds is intended...

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Aug 28, 2024

European Commission Approves Astellas’ PADCEV^TM (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer

- First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years1 -

TOKYO, August 28, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Commission has granted Marketing Authorization for PADCEV™ (enfortumab vedotin, an antibody-drug conjugate [ADC])...

Read more about European Commission Approves Astellas’ PADCEV^TM (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer
Aug 27, 2024

Astellas Initiates Phase 3 Clinical Study of Fezolinetant for VMS in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy

- HIGHLIGHT 1™ study to evaluate fezolinetant for treatment of moderate to severe vasomotor symptoms in women with stage 0-3 hormone receptor positive breast cancer receiving adjuvant endocrine therapy -

TOKYO, August 27, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced dosing of the first patient in the HIGHLIGHT 1™ Phase 3 pivotal study for fezolinetant, an investigational...

Read more about Astellas Initiates Phase 3 Clinical Study of Fezolinetant for VMS in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy
Aug 20, 2024

China’s National Medical Products Administration (NMPA) Approves PADCEV^TM (enfortumab vedotin) for Treatment of Locally Advanced or Metastatic Urothelial Cancer

- Approval based on the global EV-301 and China EV-203 trials, where enfortumab vedotin signficantly improved overall survival (OS) and objective response rate (ORR) respectively in patients following prior treatment with platinum-based chemotherapy and PD-1/L1 inhibitors1,2

TOKYO, August 20, 2024 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has...

Read more about China’s National Medical Products Administration (NMPA) Approves PADCEV^TM (enfortumab vedotin) for Treatment of Locally Advanced or Metastatic Urothelial Cancer
Aug 1, 2024

Notice Regarding Change in fair value of contingent consideration

TOKYO, August 1, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it booked ¥5.5 billion in the first quarter of fiscal year 2024 for change in the fair value of contingent...

Read more about Notice Regarding Change in fair value of contingent consideration

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