FDA converts from an accelerated to a full approval Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) in 2L+

FDA approved Kite's request for Tecartus (brexucabtagene autoleucel) to convert from Tecartus’ 2020 Accelerated Approval to a full approval for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

The full approval now includes efficacy, safety and pharmacokinetic data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor (BTKi)-naïve.

The approved supplement BLA includes the completed accelerated approval required study (ZUMA-2) final report for PMR #2 in the approval letter issued on July 24, 2020.

Under the FDA’s Accelerated Approval pathway, therapies for serious diseases can reach patients sooner based on early evidence, with the requirement that confirmatory trial(s) subsequently verify clinical benefit. Achieving traditional approval reflects the FDA’s determination that Tecartus has demonstrated a durable and well-characterized benefit-risk profile in R/R MCL.

For the first time, Tecartus U.S. Prescribing Information has also been updated to include efficacy, safety and pharmacokinetic data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor (BTKi)-naïve. Completion of this confirmatory cohort fulfills Kite’s post‑marketing commitment to the FDA. 

Link to april-1-2026-approval-letter-tecartus.pdf

Press Release U.S. FDA has granted traditional approval to Tecartus