The FDA has removed the limitations of use in patients with primary central nervous system lymphoma (PCNSL) for YESCARTA, CAR T-cell Therapy.

YESCARTA is the first and only LBCL CAR T therapy to have the PCNSL limitation removed.[1]

PCNSL is a rare and aggressive form of NHL, accounting for approximately 1% of all NHL cases, leaving patients with few treatment options. Up until now, all LBCL CAR T therapies carried FDA limitations excluding or cautioning use in this population due to concerns around neurotoxicity and limited safety data.[1-3]

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YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

  • Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. (1.1)

  • Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. (1.1)

  • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2)

Please refer to the updated Prescribing Information for full details and reach out with any questions. 

References: 1. YESCARTA® (axicabtagene ciloleucel). Prescribing information. Kite Pharma, Inc; 2026. 2. Roschewski M, Hodson DJ. Diffuse large B-cell lymphoma involving the central nervous system: biologic rationale for targeted therapy. Haematologica.2024;109(2):388-400. doi:10.3324/haematol.2021.278613 3. Tang D, Chen Y, Shi Y, et al. Epidemiologic characteristics, prognostic factors, and treatment outcomes in primary central nervous system lymphoma: a SEER-based study. Front Oncol. 2022;12:817043. doi:10.3389/fonc.2022.817043