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.
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