Axicabtagene ciloleucel approved by the EC for the treatment of DLBCL and PMBCL

On 27 August 2018, the European Commission (EC) granted a marketing authorization for axicabtagene ciloleucel (Yescarta) for the treatment of 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 European Medicine's Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for axicabtagene ciloleucel (axi-cel) on 29 June 2018. It is a CD19-directed chimeric antigen receptor CAR-T therapy that was granted PRIME status (priority medicines) by the EMA in 2016. Axi-cel was approved by the US Food and Drug Administration (FDA) on October 18 2017. 

The marketing authorization means that axi-cel will be able to be prescribed as a treatment, in accordance with the indication, in countries in the European Union and Norway, Iceland and Liechtenstein. The approval follows results from the ZUMA-1 clinical study.

Professor Frederik Locke, H.Lee Moffitt Cancer Center, Tampa, Florida, commented on the duration of response from the study at the annual meeting of the American Society of Clinical Oncology in Chicago, June 2018. "What we found was that for patients in a partial response or complete response, at three months after a single infusion of CAR-T therapy, 80% of those patients remained in remission one year after the therapy was given." He added that "many of those responses deepened over time."