FDA grants full approval of Kite’s Tecartus for mantle cell lymphoma

The U.S. FDA has granted traditional (full) approval to Kite’s CAR-T cell therapy, Tecartus (brexu-cel), for adult patients with relapsed or refractory mantle cell lymphoma (MCL).

The action converts the R/R MCL indication from accelerated approval — received in 2020 — to full approval based on 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 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.

MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the “mantle zone” of the lymph node. MCL is highly aggressive following relapse, with many patients’ disease progressing following therapy. Tecartus, a CD19-directed genetically modified autologous T cell immunotherapy, is also approved for relapsed or refractory B-cell precursor acute lymphoblastic leukemia.