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EMA validates marketing authorization application for lisocabtagene maraleucel for the treatment of adults with B-cell non-Hodgkin lymphoma

Jul 21, 2020

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.

  1. BusinessWire. European Medicines Agency validates Bristol Myers Squibb’s application for CAR T cell therapy lisocabtagene maraleucel (liso-cel). https://www.businesswire.com/news/home/20200717005025/en/. Published Jul 17, 2020. Accessed Jul 21, 2020.