Where has zolbetuximab received regulatory approval?

Published

Prescribing Information including BOXED WARNING

Australia, Brazil, Canada, China, Egypt, EU, Hong Kong, India, Israel, Japan, Macau, Malaysia, Singapore, S. Korea, Switzerland, Taiwan, Thailand, UAE, UK, 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
S. 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
Macau	18 Aug 2025¹⁴
Thailand	02 Sep 2025¹⁵
Malaysia	08 Sep 2025¹⁶
Israel	07 Dec 2025¹⁷
India	19 Dec 2025¹⁸
Egypt	25 Mar 2026¹⁹

Astellas. Press Release: Astellas’ VYLOY^TM (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 23-APR-2026.
Vyloy (zolbetuximab) Summary of Product Characteristics. Astellas Pharma. Accessed 23-APR-2026.
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/. Accessed 23-APR-2026.
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 23-APR-2026.
Vyloy. Product information. Health Canada. Available at: https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104288. Accessed 23-APR-2026.
Anvisa - Agência Nacional de Vigilância Sanitária. Consultas: VYLOY. Available at: https://consultas.anvisa.gov.br/#/medicamentos/3666672?nomeProduto=vyloy/. Accessed 23-APR-2026.
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 23-APR-2026.
Vyloy^TM 100 mg/vial powder for concentrate for solution for infusion. Department of Health - Abu Dhabi. Accessed 23-APR-2026.
Vyloy^TM Product information for human medicinal products. Swissmedic. Accessed 23-APR-2026.
Vyloy^TM 100 mg/vial powder for concentrate for solution for infusion. Singapore Health Sciences Authority. Accessed 23-APR-2026.
Vyloy® 100 mg/ml powder for concentrate for solution for infusion. Taiwan Food and Drug Administration. Accessed 23-APR-2026.
Vyloy (zolbetuximab)100 mg/ml powder for concentrate for solution for infusion. Product Information. Commonwealth of Australia: Department of Health and Aged Care, Therapeutic Goods Administration. Accessed 23-APR-2026.
Vyloy® 100 mg/vial powder for concentrate for solution for infusion. Product Information. Astellas Hong Kong. Accessed 23-APR-2026.
Vyloy 100 mg/vial powder for concentrate for solution for infusion. Thailand Food and Drug Administration, Ministry of Public Health. Accessed 23-APR-2026.
Vyloy^TM 100 mg/vial powder for concentrate for solution for infusion, Product Information. Astellas Malaysia. Accessed 23-APR-2026.
Vyloy (zolbetuximab) 100 mg/vial and 300 mg/vial powder for concentrate for solution for infusion. Product Information. Ministry of Health, State of Israel. Accessed 23-APR-2026.
Vyloy^TM (zolbetuximab) 100 mg/vial and 300 mg/vial powder for concentrate for solution for infusion, Product Information. Astellas India. Accessed 23-APR-2026.
Vyloy® 100 mg/ml powder for concentrate for solution for infusion. Product Information. Egyptian Drug Authority. Accessed 23-APR-2026.