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Axicabtagene ciloleucel receives US FDA approval as second-line treatment for large B-cell lymphoma

Apr 5, 2022
Learning objective: After reading this article, learners will be able to cite a new clinical development in lymphoma/CLL

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On April 1, 2022, it was announced that the U.S. Food and Drug Administration (FDA) had granted approval to the chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel (axi-cel) for adult patients with large B-cell lymphoma (LBCL) who have relapsed within 12 months of, or who are refractory to, first-line chemoimmunotherapy.1 This change in authorization could expand the pool of those eligible for CAR T-cell therapy by up to 11,000 patients in the U.S. alone.1 LBCL is the most commonly diagnosed form of non-Hodgkin lymphoma globally.2

The approval is based on key data obtained from the ZUMA-7 trial.

  • Patients treated with axi-cel were 2.5 times more likely to be alive at 2 years without the need for additional treatment compared with those who received standard of care treatment.
  • Axi-cel also demonstrated improvements to objective response rate and overall survival compared with standard of care treatment.
  • Axi-cel had an acceptable safety profile, consistent with previous studies.

This approval could help to address an area of unmet need for patients with LBCL who do not respond well to high-dose chemoimmunotherapy.

  1. Gilead. Yescarta® receives U.S. FDA approval as first CAR T-cell therapy for initial treatment of relapsed or refractory large B-cell lymphoma (LBCL). Published Apr 01, 2022. Accessed Apr 04, 2022.
  2. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-249. DOI: 10.3322/caac.21660

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