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15-05-2018 | FDA | News | Article

approvalsWatch

Tisagenlecleucel approved for relapsed, refractory DLBCL

medwireNews: The US FDA has approved the use of tisagenlecleucel for the treatment of adults with large B-cell lymphoma who have relapsed or refractory disease after at least two lines of systemic chemotherapy.

The CD-19-directed genetically modified autologous T-cell immunotherapy may be used for patients with forms of the disease including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

The recommended dosage has been set at 0.6–6.0 x 108 CAR-positive viable T cells following the results of the phase II JULIET study, which demonstrated an overall response rate of 50%, including a complete response in 32%, of patients.

The FDA has also approved use of a Risk Evaluation and Mitigation Strategy for management of the serious risks associated with cytokine release syndrome and neurological toxicity during tisagenlecleucel treatment.

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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