Imminent launch of the 3rd new CAR-T-cell therapy 'Yescarta'

in KOR

Gilead Sciences submitted an approval application to the Ministry of Food and Drug Safety (MFDS)

One shot option that can be used as second·third-line treatments for blood cancers, including DLBCL

Product photo of Gilead Sciences

The third CAR-T-cell therapy 'Yescarta' is expected to be commercialized in South Korea.

 

According to industry sources, Gilead Sciences submitted documentation for the approval of the CAR-T-cell therapy, Yescarta (axicabtagene ciloleucel), and the Ministry of Food and Drug Safety (MFDS) is currently conducting the review.

 

Yescarta was designated an orphan drug by the MFDS in September last year.

 

The designated indication includes ▲Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL) who have undergone two or more systemic treatments ▲Adult patients with DLBCL who have relapsed or refractory within 12 months after the first-line chemoimmunotherapy.

 

Yescartav is a CAR-T cell therapy that received the first approval from the U.S.

 

Food and Drug Administration (FDA) as the third-line treatment in October 2017.

 

After receiving approval from the European Commission (EC), the drug has expanded to the second-line treatment.

 

In 2021, it became available for use in treating follicular lymphoma.

 

The efficacy of Yescarta as the third-line treatment has been confirmed through the ZUM-1 clinical study.

 

The study reported a 5-year survival rate, showing that 42.6% of all patients treated with Yescarta survived for five years, and 92% of those no longer needed additional cancer treatment.

 

The ZUMA-7 Phase 3 clinical trial confirmed the drug's efficacy for the second-line treatment.

 

It was the first-in-class for a CART-T cell therapy, the largest in scale, and the longest follow-up trial.

 

359 patients world-wide were randomly assigned to receive one-time treatment of Yescarta or the existing standard-care second-line therapy.

 

The analysis results presented at the American Society of Clinical Oncology conference (ASCO 2023) last year included a median follow-up at 47.2 months, at which the median value of overall survival (OS) with Yescarta was not reached.

 

However, Yescarta's death rate was 27%, which was statistically lower than the control group's 31.1 months.

 

The OS at 48 months was 54.6% for Yescarta and 46.0% for the control group.

 

Yescarta treatment showed consistent survival benefits in pre-assigned subgroups, including age groups, refractory at the first-line therapy, early relapse, or high-grade B-cell lymphoma (HGBL).

 

Additionally, excluding the impact of treatment switching using the pre-assigned method, Yescarta's risk of death was 39% lower than the control group.

 

In South Korea, Novartis Korea's 'Kymriah (tisagenlecleucel)' was the first CAR-T-cell therapy to receive approval.

 

In March 2024, Janssen Korea's 'Carvykti (ciltacabtagene autoleucel)' also received approved.

 

Kymriah is now added to the insurance reimbursement list, and Carvykti is still a non-reimbursed drug.