The FDA has granted traditional (full) approval to Kite’s CAR T‑cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL). The decision converts Tecartus’ 2020 accelerated approval in this indication to full approval, based on the totality of evidence from the Phase 2 ZUMA‑2 study, including new confirmatory data from Cohort 3. Cohort 3 enrolled patients with relapsed or refractory MCL after at least one prior line of therapy who were Bruton tyrosine kinase inhibitor (BTKi)‑naïve.
According to Gilead, Cohort 3 demonstrated high response rates, including deep and durable remissions, with a safety profile consistent with prior Tecartus experience. The updated U.S. prescribing information now includes Cohort 3 efficacy, safety and pharmacokinetic data and fulfills Kite’s post‑marketing requirement to verify and describe clinical benefit under the FDA’s Accelerated Approval pathway. Gallia Levy, MD, PhD, Senior Vice President and Global Head of Development at Kite, said the full approval “reflects meaningful progress” and supports Tecartus as a potential second‑line treatment option for appropriate patients whose MCL has returned.
In pooled safety data from ZUMA‑2 Cohorts 1–3 (N=168), cytokine release syndrome occurred in 93% of patients, with Grade 3 or higher CRS in 12%, and neurologic events in 80% of patients, including Grade 3 or higher in 33%. Tecartus remains a CD19‑directed genetically modified autologous T‑cell immunotherapy also approved in the United States for relapsed or refractory B‑cell precursor acute lymphoblastic leukemia.
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