1.United States (August 2017):
The United States was the first country in the world to approve CAR-T cell therapy. On August 30, 2017, the U.S. Food and Drug Administration (FDA) approved Novartis’ Kymriah for the treatment of specific types of acute lymphoblastic leukemia (ALL) patients. Shortly thereafter, on October 18, 2017, Gilead’s Kite Pharma’s Yescarta also received FDA approval for the treatment of specific types of non-Hodgkin’s lymphoma.
2.European Union (August 2018):
The European Medicines Agency (EMA) approved both Kymriah and Yescarta almost simultaneously in August 2018, enabling their use in all EU member states, as well as Iceland, Norway, and Liechtenstein. This marked the official start of CAR-T therapy in Europe.
3.Canada (September 2018):
Following closely behind the EU, Health Canada approved Novartis’ Kymriah in September 2018, making it the first CAR-T cell therapy to receive regulatory approval in Canada. Subsequently, Gilead’s Yescarta also received approval in February 2019.
4.Australia (December 2018):
The Australian Therapeutic Goods Administration (TGA) approved Kymriah in December 2018, making it the first approved CAR-T therapy in the country. In 2019, the therapy began to be eligible for medical insurance reimbursement for the treatment of specific leukemia patients. In 2021, Australia approved the local production of CAR-T cells, further improving access to treatment.
5.Japan (March 2019):
Japan approved Novartis’ Kymriah in March 2019, becoming the first country in Asia to approve the therapy. This move also drove the development of CAR-T therapy in other parts of Asia.
6.Singapore (March 2021):
The Health Sciences Authority (HSA) of Singapore approved Kymriah in March 2021, making it the first commercially approved CAR-T therapy in Southeast Asia. This also makes Singapore an important regional cancer treatment center.
7.China (June 2021):
On June 22, 2021, China’s NMPA approved axicabtagene ciloleucel (Yescarta®), brought in by Fosun Kite, as the first CAR-T therapy in the country. By September 2025, eight more Chinese companies – JW Therapeutics, IASO Biopharma, Innovent Biologics, Heurobel Therapeutics, CARsgen Therapeutics, Legend Biotech, and Hebecell Corporation – had also gained approval for their own CAR-T products, fostering growth in China’s cell therapy sector.
8.Israel (Approximately 2021):
Research and application in CAR-T therapy in Israel is at the forefront of the world as well. In addition to providing FDA-approved commercial CAR-T therapies, Israeli medical institutions also independently develop and conduct CAR-T clinical trials and treatments. Although the exact date of initial approval of commercial products is less clear than other countries, patients in Israel have been receiving locally developed CAR-T treatments since 2021.
9.Brazil (February 2022):
The Brazilian National Health Surveillance Agency (ANVISA) approved Novartis’ Kymriah in February 2022, marking the official entry of CAR-T therapy into Latin America.
10.South Korea (April 2022):
South Korea included Kymriah in the national health insurance coverage in April 2022, making the therapy more accessible in Korea. This decision by the government greatly reduced the financial burden on patients.
It is worth noting that CAR-T therapy clinical trials are being conducted in more countries and regions around the world, and it is expected that more countries will approve and establish legitimate treatment institutions in the future. However, the high cost of treatment and complex production and logistics processes remain major challenges that limit its widespread application worldwide.
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