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Axi-cel receives positive opinion by the European CHMP for R/R DLBCL and PMBCL
On 29 June 2018, the European Medicine's Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for axi-cel (YESCARTA) for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic therapy.
Axi-cel is a CD19-directed chimeric antigen receptor CAR-T therapy that was granted PRIME status (priority medicines) by the EMA in 2016.
The drug was approved for the treatment of relapsed/refractory (R/R) adult B-cell lymphomas including diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL) by the US Food and Drug Administration on 18th October 2017. At the interim and primary analyses of ZUMA-1, Axi-Cel met its primary endpoint that led to its approval in the US.