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2022-06-28T15:16:40.000Z

Lisocabtagene maraleucel receives FDA approval for the second-line treatment of large B-cell lymphoma

Jun 28, 2022
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Learning objective: After reading this article, learners will be able to cite a new clinical development in lymphoma/CLL

On June 24, 2022, it was announced that the U.S. Food and Drug Administration (FDA) had granted approval to lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell product, for the treatment of relapsed or refractory large B-cell lymphoma in adult patients who have already received ≥1 line of systemic therapy. The approval is based on key data obtained from the phase III TRANSFORM and phase II PILOT studies (NCT03575351; NCT03483103). 1

The approval encompasses patients with diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma Grade 3B, who have:

  • Disease that is refractory to first-line chemoimmunotherapy or relapses within 1 year of first-line chemoimmunotherapy; or
  • Disease that is refractory to first-line chemoimmunotherapy or relapses after first-line chemoimmunotherapy that is not eligible for hematopoietic stem cell transplant.

Liso-cel has demonstrated deep and durable responses in these patient groups, while also exhibiting a tolerable safety profile. The approval comes shortly after news of the European Commission approval of liso-cel for the ≥3rd line treatment of certain forms of relapsed or refractory large B-cell lymphoma, as previously reported on the Lymphoma Hub.

  1. Bristol Myers Squib. U.S. FDA approves Bristol Myers Squibb’s CAR T cell therapy Breyanzi® for relapsed or refractory large B-cell lymphoma after one prior therapy. https://investors.bms.com/iframes/press-releases/press-release-details/2022/U.S.-FDA-Approves-Bristol-Myers-Squibbs-CAR-T-Cell-Therapy-Breyanzifor-Relapsed-or-Refractory-Large-B-cell-Lymphoma-After-One-Prior-Therapy/default.aspx. Published June 24, 2022. Accessed June 27, 2022.

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