Focus of the Report: This report evaluates the use of axicabtagene ciloleucel (Yescarta) for the treatment of relapsed or refractory (r/r) large B-cell lymphoma (LBCL).

Technology Description: Axicabtagene ciloleucel therapy is a form of chimeric antigen receptor (CAR) T-lymphocyte (T-cell) therapy that involves adoptive cell transfer. T cells are collected from the patient and genetically modified using viral vectors to express CD19 cell receptors that are highly specific for B-lymphocyte (B-cell) antigens. The modified T cells are then infused back into the patient’s body to target the patient’s own B-cell malignancy.

Controversy: CAR T-cell therapy is a resource-intensive technology that is associated with a notably high cost. There are reports of serious complications associated with CAR T-cell therapy, including CRS and neurologic toxicities, which can lead to death. Despite the significant potential for adverse events, there is preliminary evidence of high response rates and a marked interest in using these genetically modified cells for patients with r/r disease and a poor prognosis.

Key Questions:

  • Is axicabtagene ciloleucel therapy effective for improving remission and survival in patients with r/r LBCL?

  • How does axicabtagene ciloleucel therapy compare with alternative treatments (e.g., tisagenlecleucel [Kymriah], chemotherapy, hematopoietic stem cell transplant [HSCT])?

  • Is axicabtagene ciloleucel therapy safe?

  • Have specific patient selection criteria been identified for the use of axicabtagene ciloleucel therapy for the treatment of LBCL?

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