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Tisagenlecleucel receives FDA approval for the treatment of relapsed or refractory follicular lymphoma

Jun 1, 2022
Learning objective: After reading this article, learners will be able to cite a new clinical development in follicular lymphoma

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On May 28, 2022, it was announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for the use of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell product, for the treatment of adult patients with relapsed or refractory follicular lymphoma who have previously received ≥2 lines of systemic therapy.1 To conform with the accelerated approval program, continued approval in this setting may be dependent upon verification and proven clinical benefit in a confirmatory trial(s). This approval marks the third indication that tisagenlecleucel has received FDA approval for, and it remains the only CAR T-cell therapy approved in both adult and pediatric settings. The approval is based on pivotal data obtained from the phase II ELARA trial (NCT03568461),1 previously reported on the Lymphoma Hub.


  • 86% overall response rate
  • 68% complete response rate
  • 85% of patients who achieved a complete response were still in response 12 months later


  • 53% of patients experienced any-grade cytokine release syndrome (none were Grade 3/4)
  • 43% of patients experienced any-grade neurologic events, with 6% being Grade 3/4
  • 18% of patients were infused in an outpatient setting

  1. Novartis. FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma. Published May 28, 2022. Accessed May 31, 2022.

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