European Commission grants conditional approval to Tecartus for relapsed or refractory mantle cell lymphoma. Kite/Gilead

Kite, a Gilead Company announced that the European Commission has granted conditional marketing authorization for Tecartus (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy 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. Conditional authorization is granted in the interest of public health where the benefit of immediate availability outweighs the risk of less comprehensive data available. The conditional marketing authorization is supported from the multinational, single-arm, Phase II open-label ZUMA-2 pivotal trial in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor. ZUMA-2 demonstrated an overall response rate (complete or partial) of 93 percent, with 67 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of Tecartus. In the safety analyses, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were observed in 15 percent and 33 percent of patients, respectively.