FDA
FDA converts Tecartus’ mantle cell lymphoma indication to full approval
On April 2, 2026, FDA granted traditional (full) approval to CAR T‑cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL), converting the product’s accelerated approval into a permanent indication.
According to a company press release, the decision was based on confirmatory results from the ZUMA‑2 study, including data from Cohort 3 involving patients who were Bruton tyrosine kinase inhibitor–naïve. Across cohorts, Tecartus demonstrated high response rates, durable efficacy, and a safety profile consistent with prior experience, fulfilling Kite’s post‑marketing commitment under FDA’s accelerated approval pathway.
MCL is a rare and aggressive form of non‑Hodgkin lymphoma, and treatment options become limited after relapse. The full approval positions Tecartus as a key option after one or more prior lines of therapy.
“The full approval of Tecartus for adults with relapsed or refractory mantle cell lymphoma reflects meaningful progress,” said Gallia Levy, MD, PhD, senior vice president and global head of development at Kite.
With this action, Tecartus’ label now reflects the totality of evidence from ZUMA‑2, reinforcing confidence in the therapy’s clinical benefit for appropriate patients.