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16-07-2018 | EMA | News

approvalsWatch

EMA recommends two CAR T-cell therapies for approval

medwireNews: Marketing authorizations have been recommended by the EMA for use of the chimeric antigen receptors (CAR) T-cell therapies tisagenlecleucel and axicabtagene ciloleucel for the treatment of specific blood cancers.

Tisagenlecleucel has been given a positive opinion for use in pediatric patients and young adults up to age 25 years with B-cell acute lymphoblastic leukemia that is treatment-refractory, has relapsed after transplantation, or has relapsed at least twice.

This CAR T-cell therapy will also be available for adults with diffuse large B-cell lymphoma (DLBCL) who have previously received at least two lines of systemic treatment.

Axicabtagene ciloleucel has also been granted a position opinion for marketing authorization in patients with relapsed or refractory DLBCL, as well as for patients with primary mediastinal large B-cell lymphoma who have previously received two or more systemic agents.

In addition, the Committee for Medicinal Products for Human Use has also recommended that the therapeutic indication for the immunosuppressive agent tocilizumab now include the treatment of CAR T-cell-induced cytokine release syndrome.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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