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.
- The ORR was consistent across subgroups = 52% (95% CI, 41%-62%); 40% complete response and 12% partial response
- At 14 months median follow-up the median DOR was not reached
- The 12-month relapse-free survival rate was 78.5% (95% CI, 60%-89%) among patients with a complete response and 65% (95% CI, 49%-78%) among all responders
- For patients with a complete response, the median OS was not reached and for all patients, the OS was 11.7 months (95% CI, 6.6-not reached)