Posted by Michael Wonder on 01 Jul 2018
European CHMP adopts positive opinion for Yescarta (axicabtagene ciloleucel) for the treatment of relapsed or refractory DLBCL and PMBCL, after two or more lines of systemic therapy
29 June 2018 - Kite, a Gilead Company, today announced that the EMA's CHMP has issued a positive opinion on the company’s marketing authorisation application for Yescarta (axicabtagene ciloleucel) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
The application is supported by data from the ZUMA-1 trial of axicabtagene ciloleucel in adult patients with refractory aggressive NHL. In the single-arm trial, 72% of patients (n=73/101) who received a single infusion of axicabtagene ciloleucel responded to therapy with 51% (n=52/101) achieving a complete response (as assessed by an independent review committee, median follow up of 15.1 months). Grade 3 or higher adverse events reported during ZUMA-1 included, but were not restricted to, cytokine release syndrome (CRS), neurologic events and cytopenias.
