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  • Gilead¡¯s Yescarta approved in KOR...3rd CAR-T therapy
  • by Lee, Hye-Kyung | translator Alice Kang | Aug 14, 2025 06:13am
Approved by the US FDA in 2017... Designated as an orphan drug in Korea last September
The third CAR-T therapy has been approved in Korea.

The Ministry of Food and Drug Safety approved Gilead Sciences Korea's Yescarta (axicabtagene ciloleucel) today (13th).

Yescarta is a CAR-T therapy that received approval from the U.S. FDA in 2017 and the European EMA in 2018. Last year, the EMA approved it as a second-line treatment for patients with adult diffuse large B-cell lymphoma and B-cell acute lymphoblastic leukemia.

In June, the FDA expanded the indication for Yescarta to include patients with follicular lymphoma.

In Korea, after the drug was designated as an orphan drug by the MFDS in September last year, it has been undergoing the formal approval process.

According to a brief issued by the
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