Where has zolbetuximab received regulatory approval?

Published

Prescribing Information including BOXED WARNING

Australia, Brazil, Canada, China, EU, Hong Kong, Japan, Malaysia, Singapore, South Korea, Switzerland, Taiwan, Thailand, UAE, UK, and US

Astellas has submitted applications for zolbetuximab to regulatory agencies around the world. At this time, Astellas is unable to provide further information on upcoming approval timelines as review is ongoing.

Table 1. Zolbetuximab approval dates by country or region

Location	Approval date
Japan	26 Mar 2024¹
United Kingdom (UK)	14 Aug 2024²
European Union (EU)	19 Sep 2024³
South Korea	20 Sep 2024⁴
United States of America (US)	18 Oct 2024⁵
Canada	13 Dec 2024⁶
Brazil	16 Dec 2024⁷
China	25 Dec 2024⁸
United Arab Emirates (UAE)	23 Jan 2025⁹
Switzerland	19 Feb 2025¹⁰
Singapore	06 Mar 2025¹¹
Taiwan	12 Mar 2025¹²
Australia	17 Mar 2025¹³
Hong Kong	06 Aug 2025¹⁴
Thailand	02 Sep 2025¹⁵
Malaysia	08 Sep 2025¹⁶

Astellas. Press Release: Astellas’ VYLOY® (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer. Available at: https://newsroom.astellas.com/2024-03-26-Astellas-VYLOY-TM-zolbetuximab-Approved-in-Japan-for-Treatment-of-Gastric-Cancer.
Zolbetuximab Approved to Treat Adults with Stomach or Gastro-oesophageal Junction Cancer - GOV.UK. Available at: https://www.gov.uk/government/news/mhra-approves-zolbetuximab. Accessed 31OCT2025.
VYLOY (zolbetuximab) Summary of Product Characteristics. Astellas Pharma. Accessed 31OCT2025.
Vyloy (zolbetuximab) approval in Korea. Ministry of Food and Drug Safety. Available at: https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=202402279aupdateTs2024-09-20%2017:23:38.370648b.
Astellas. Astellas’ VYLOY (zolbetuximab) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer. Available at: https://www.astellas.com/en/news/29291. Accessed 31OCT2025.
Health Canada. Product information: VYLOY. Available at: https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104288. Accessed 31OCT2025.
Anvisa - Agência Nacional de Vigilância Sanitária. Consultas: VYLOY. Available at: https://consultas.anvisa.gov.br/#/medicamentos/3666672?nomeProduto=vyloy. Accessed 31OCT2025.
National Medical Products Administration (NMPA). The State Food and Drug Administration approves the launch of zolbetuximab for injection. Available at: https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241231171015164.html. Accessed 31OCT2025
Department of Health - Abu Dhabi. Vyloy® 100 mg powder for concentrate for solution for infusion. Accessed 31OCT2025.
Swissmedic. Product information for human medicinal products: VYLOY®.
Singapore Health Sciences Authority. VYLOY® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL. Accessed 31OCT2025.
Taiwan Food and Drug Administration. VYLOY® Powder for concentrate for solution for infusion 100 mg. Accessed 31OCT2025.
Commonwealth of Australia: Department of Health and Aged Care, Therapeutic Goods Administration. AUSTRALIAN PRODUCT INFORMATION - VYLOY (ZOLBETUXIMAB). Accessed 31OCT2025.
Vyloy® Powder for concentrate for solution for infusion 100 mg, Product Information. Astellas Hong Kong.
Thailand Food and Drug Administration, Ministry of Public Health. VYLOY 100 mg Powder for concentrate for solution for infusion. Accessed 31OCT2025.
Vyloy® 100 mg/vial powder for concentrate for solution for infusion, Product Information. Astellas Malaysia.