Policy & Advocacy

FDA Approves First CAR T-Cell Therapy for ALL

ASGCT Staff - October 14, 2021

This marks approval of a second disease indication for Tecartus, which received accelerated approval for the treatment of adults with r/r mantle cell lymphoma in July 2020.

Earlier this month, the Food and Drug Administration (FDA) approved brexucabtagene autoleucel (Tecartus) for a new indication—adult patients (18 years and older) with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL). This approval makes Tecartus the first CAR T-cell therapy for ALL for adults. Tecartus received accelerated approval for another indication, adults with r/r mantle cell lymphoma, in July 2020.

“There is a large population of adult patients with ALL who had relapsed or refractory ALL who did not have an option outside a clinical trial and now have access to an approved CAR-T therapy,” said ASGCT Past President Helen E. Heslop, MD, DSc. (Hon).

This CD19-directed CAR T-cell therapy resulted in a 52 percent complete response within three months in a single-arm multicenter trial in the new treatment population, with median duration not reached at 7.1 months median follow-up. The FDA granted the approval to Kite Pharma, Inc., a Gilead Company, which received priority review, breakthrough designation, and orphan drug designation for this application.

Tecartus is one of eight gene therapies approved in the U.S., as defined in ASGCT’s series of quarterly landscape reports, and is one of five approved CAR T-cell therapies. Novartis’ tisagenlecleucel (Kymriah) treats a slightly overlapping population of pediatric and young adult patients (age 3-25 years) with B-cell precursor ALL that is refractory or in second or later relapse.


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