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On 27 August 2018, the European Commission (EC) granted a marketing authorization for tisagenlecleucel (Kymriah) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
The US Food and Drug Administration (FDA) approved tisagenlecleucel for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma and transformed follicular lymphoma (tFL) on 01 May 2018.
The approval was supported by data from the JULIET study. Updated results from the study were presented at the 23rd Congress of the European Hematology Association (EHA) in Stockholm, 2018.
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