Gilead’s Yescarta approved in KOR...3rd CAR-T therapy

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 Korea Biotechnology Organization, Yescarta is currently the CAR-T therapy with the highest market share worldwide.

 

Posting sales of USD 1.5 billion (approximately KRW 2 trillion) last year, Yescarta ranked first with a 40% share of the entire CAR-T market.

 

It was followed by Novartis' Kymriah posting USD 500 million (approximately KRW 700 billion), Johnson & Johnson's ‘Carvykti’ at USD 500 million, BMS's ‘Abecma’ at USD 470 million (approximately KRW 650 billion), and Gilead Sciences' ‘Tecartus’ at USD 370 million (approximately KRW 500 billion).

 

Kymriah and Carvykti have already been granted marketing authorization in Korea.

 

Meanwhile, according to an analysis presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, at a median follow-up of 47.2 months, the overall survival (OS) in the Yescarta treatment group had not yet reached the median, while the placebo group had a median OS of 31.1 months, indicating a statistically significant 27% lower risk of death with Yescarta.

 

The estimated 48-month overall survival rate was 54.6% for Yescarta and 46.0% for the control group, with Yescarta demonstrating consistent survival benefits across pre-specified subgroups, including age, primary resistance, early relapse, and high-grade B-cell lymphoma.