Hematological Neoplasms

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.

On April 1, 2022, Kite, a subsidiary of Gilead Sciences, announced that the U.S. Food and Drug Administration (FDA) has approved their CAR-T cell therapy product Yescarta® for the treatment of adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months after first-line chemoimmunotherapy.

On October 17, 2022, exciting news came from the European Commission (EC). Based on the data from the ZUMA-7 study, the EC officially approved a new indication for Yescarta® for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) after one line of chemoimmunotherapy failed or within 12 months of first-line chemoimmunotherapy.

On December 17, 2020, Gilead’s subsidiary Kite’s CD19 CAR-T cell therapy Tecartus (KTE-X19) received conditional marketing authorization in the European Union for the treatment of relapsed or refractory mantle cell lymphoma (r/r MCL).

This article delves into the specifics of Kymriah’s EMA approval, its mechanisms, clinical trial data, and its impact on patient care.

On May 1, 2018, the U.S. Food and Drug Administration (FDA) approved Novartis’ Tisagenlecleucel (Kymriah) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (FL).