On July 17, 2020, the European Medicines Agency (EMA) validated the marketing authorization application for lisocabtagene maraleucel (liso-cel), for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and follicular lymphoma Grade 3B (FL3B) after at least two prior therapies.
Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy targeting CD19. The application was based on the results from
- the phase I TRANSCEND-NHL-001 (NCT02631044) study evaluating safety, antitumor activity, and pharmacokinetics of liso-cel in patients with R/R B-cell non-Hodgkin lymphoma, including DLBCL, high-grade lymphoma, PMBCL and FL3B
- the phase II TRANSCEND WORLD 001 study evaluating efficacy and safety of liso-cel in patients with aggressive B-cell non-Hodgkin lymphoma
With the validation of the application, the EMA can now start the centralized review process.