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Axicabtagene Ciloleucel Approaches EU Approval for DLBCL, PMBCL

Jason M. Broderick @jasoncology
Published: Friday, Jun 29, 2018

Alessandro Riva

Alessandro Riva, MD

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of axicabtagene ciloleucel (axi-cel; Yescarta) as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or primary mediastinal large B-cell lymphoma (PMBCL), following at least 2 lines of systemic therapy, according to Kite (Gilead), the manufacturer of the CAR T-cell therapy.  

The approval included boxed warning regarding CRS. To address the risk of CRS and neurologic toxicities, the FDA approved axi-cel with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). Additionally, certification and training will be required before hospitals will be cleared to administer the T cell therapy. The required training will focus on identifying and managing CRS and neurologic toxicity.
Locke FL, Neelapu SS, Bartlett NL, et al. Primary results from ZUMA-1: a pivotal trial of axicabtagene ciloleucel (Axi-cel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (NHL). Presented at: 2017 AACR Annual Meeting; April 1-5, 2017; Washington, DC. Abstract CT019.

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