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Gilead Nabs Second Approval for CAR T Lymphoma Drug

Gilead Sciences’ anti-CD19 CAR T-cell therapy, Tecartus (brexucabtagene autoleucel), has gained a second indication as the first-ever CAR T therapy for patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Текартус»: новый CAR-T-препарат против мантийноклеточной лимфомы | МОСМЕДПРЕПАРАТЫ

The drug, manufactured by Gilead subsidiary Kite Pharmaceuticals, was approved by the FDA in March for adult patients with relapsed or refractory mantle cell lymphoma (MCL).

The latest approval was based on positive results from the phase 1/2 study in which 55 patients received the therapy. At the median follow-up of 16.4 months, 31 (56 percent) were in complete remission and the median overall survival was 18.2 months.

October 6, 2021

https://www.fdanews.com/

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