The U.S. Food and Drug Administration (FDA) has granted traditional (full) approval to Kite’s CAR T-cell therapy, Tecartus (brexucabtagene autoleucel), for adult patients with relapsed or refractory (R/R) 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.
Today’s action converts the R/R MCL indication to full approval based on the totality of evidence from ZUMA-2, including confirmatory data from Cohort 3, which demonstrated high response rates, durable efficacy outcomes and a manageable safety profile consistent with prior experience. This milestone fulfills Kite’s post-marketing requirement for verification and description of clinical benefit in a confirmatory trial under the FDA’s Accelerated Approval pathway for Tecartus in R/R MCL.
“The full approval of brexu-cel in relapsed or refractory mantle cell lymphoma, along with the inclusion of Cohort 3 data in the label, reinforces our confidence in the overall profile of brexu-cel,” said Michael Wang, M.D., ZUMA-2 Lead Investigator and Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “The Cohort 3 results showed high response rates, including deep remissions, in patients who were Bruton tyrosine kinase inhibitor-naïve, with a manageable safety profile consistent with prior experience. These data provide important information to help guide treatment decisions in the relapsed or refractory setting for appropriate patients.”
MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the “mantle zone” of the lymph node and predominantly affects men over the age of 60. Approximately 33,000 people worldwide are diagnosed with MCL each year. MCL is highly aggressive following relapse, with many patients’ disease progressing following 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, Kite. “For those whose cancer has returned, the data support Tecartus as a second-line treatment option with the potential to deliver long-term remission.”
Data Supporting Full Approval of Tecartus in R/R MCL
ZUMA-2 is a single-arm, open-label, multicenter study evaluating Tecartus in adult patients with R/R MCL. Cohorts 1 and 2 evaluated Tecartus in patients who had previously received up to five lines of therapy including anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody and a BTKi. Cohort 3 evaluated Tecartus in patients who had received up to five prior lines of therapy and were BTKi-naïve. A total of 82 patients were treated in Cohorts 1 and 2, and 86 patients were treated in Cohort 3. The primary endpoint across the study was objective response rate (ORR) per the Lugano Classification (2014), as assessed by an Independent Radiologic Review Committee.
