Lymphoma

As of May 1, 2018, the FDA has approved Novartis’ CD19-targeted CAR-T therapy tisagenlecleucel (Kymriah) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Kymriah (tisagenlecleucel) is a groundbreaking chimeric antigen receptor T-cell (CAR-T) therapy developed by Novartis. It represents a novel approach to cancer treatment by using the patient’s own genetically modified T-cells to target and kill cancer cells.

Axicabtagene ciloleucel (axi-cel, Yescarta) and tisagenlecleucel (tisa-cel, Kymriah) were the first two CAR-T products approved in Europe for the treatment of relapsed/refractory large B-cell lymphoma (R/R LBCL) patients, and they have accumulated some real-world experience.

The ZUMA-2 study found that the CD19 CAR-T cell product Tecartus (Brexucabtagene Autoleucel, brexu-cel) demonstrated favorable efficacy and safety profiles, and other real-world studies have also confirmed its efficacy to be similar to the ZUMA-2 study.

Currently, two CAR-T products from Kite have been approved by the Food and Drug Administration (FDA) in the United States: Yescarta (Axicabtagene ciloleucel) and Tecartus (Brexucabtagene autoleucel).

Kite Pharma has been at the forefront of car-t therapy development. Two key products, yescarta (axicabtagene ciloleucel) and tecartus (brexucabtagene autoleucel), have been approved for use in many regions of the world.

On July 10, 2024, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) announced on its official website that the 1st-class innovative drug BRD-01, an anti-CD30 chimeric antigen receptor (CAR) autologous T-cell injection developed by Minghui (Nanjing) Gene Biotechnology Co., Ltd. (hereinafter referred to as “Minghui Gene”), has been approved for clinical trials.

On April 1, 2022, the FDA announced the approval of a new second-line treatment indication for Axicabtagene Ciloleucel (Yescarta, Axi-Cel) for adult patients with large B-cell lymphoma that is refractory to or relapses within 12 months after first-line chemoimmunotherapy.

On May 27, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

However, on Tuesday (January 23), the FDA website showed that the warning for Tecartus had been removed, and in a subsequent update, the FDA decided to modify the language in the therapy notification letters, seemingly granting Tecartus some leeway.