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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

Mar 26, 2024

Astellas’ VYLOY^TM (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer

VYLOY approved in combination with chemotherapy for patients with human epidermal growth factor receptor 2 (HER2)-negative, CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer

TOKYO, March 26, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on March 26, 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYLOY™ (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients...

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Mar 22, 2024

Astellas Receives Positive CHMP Opinion for XTANDI^TM in Additional Recurrent Early Prostate Cancer Treatment Setting

- If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk biochemical recurrent non-metastatic hormone sensitive prostate cancer patient populations in the European Union (EU)

TOKYO, March 22, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDITM (enzalutamide) as monotherapy...

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Mar 4, 2024

Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS Associated with Menopause in Japan

TOKYO, March 4, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced dosing of the first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms...

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Feb 16, 2024

Astellas and Kelonia Therapeutics Enter into Research and License Agreement to Develop Novel Immuno-Oncology Therapeutics

- Innovative universal, off-the-shelf in vivo CAR-T Cell therapy -

TOKYO and BOSTON, Mass., February 15, 2024 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Kelonia Therapeutics (CEO, Founder: Kevin Friedman, Ph.D., “Kelonia”) today announced that Xyphos Biosciences, Inc., (a wholly...

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Feb 15, 2024

PADCEV^TM (enfortumab vedotin (genetical recombination)) with KEYTRUDA^® (pembrolizumab (genetical recombination)) Granted Priority Review by Japan’s Ministry of Health, Labour and Welfare for First-Line Treatment of Advanced Bladder Cancer

- Priority review designation is based on results from the Phase 3 EV-302 trial, which found enfortumab vedotin plus pembrolizumab significantly extended overall survival and progression free survival compared to platinum-containing chemotherapy-

TOKYO, Feb. 15, 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 granted priority review for the company’s Supplemental New Drug Application (sNDA) for PADCEV™ (enfortumab vedotin...

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