CHMP recommends approval of KTE X19 in mantle cell lymphoma.- Kite/Gilead

Kite, a Gilead Company, announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company’s Marketing Authorization Application for KTE X19 (brexucabtagene autoleucel), a chimeric antigen receptor (CAR) T cell therapy, as a potential treatment for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. The CHMP opinion recommends conditional authorization, an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. The CHMP recommendation was based on the positive benefit-risk for KTE X19 as demonstrated from the safety and efficacy results of the ZUMA-2 trial. The Marketing Authorization Application of KTE X19 is supported by data from the ongoing, multinational, single arm, Phase II, open-label ZUMA-2 pivotal trial. The study enrolled 74 adult patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a Bruton tyrosine kinase inhibitor (ibrutinib or acalabrutinib). The primary endpoint was objective response rate per the Lugano Classification (2014), defined as the combined rate of complete response and partial responses as assessed by an Independent Radiologic Review Committee. KTE X19 was manufactured for 71 patients and administered to 68 patients.