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ARTICLE | Regulation

Gilead expands CAR T into adult ALL with Tecartus sBLA approval

FDA decision marks the company’s first cell therapy approval in leukemia

October 1, 2021 11:54 PM UTC

CAR Ts are now moving into adult patients with acute lymphoblastic leukemia following FDA’s approval of Tecartus, Gilead’s first for a cell therapy in leukemia.

The approval of Tecartus brexucabtagene autoleucel from Gilead Sciences Inc. (NASDAQ:GILD) for adult patients with ALL is based on data from the Phase I/II ZUMA-3 trial that showed a 71% complete response (CR) rate. Tecartus, which is already approved to treat mantle cell lymphoma (MCL), is the first CAR T therapy approved for adults with relapsed or refractory ALL...

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