Focus of the Report: This report evaluates the use of tisagenlecleucel (Kymriah) for the treatment of relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) or r/r diffuse large B-cell lymphoma (DLBCL).
Technology Description: Tisagenlecleucel therapy is a form of chimeric antigen receptor (CAR) T-lymphocytes (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. Modified T cells are then infused back into a patient’s body in order to target the patient’s own B-cell malignancy.
Controversy: CAR T-cell therapy is a relatively novel technology that is associated with a notably high cost. There are reports of serious complications associated with CAR T-cell therapy, including cytokine release syndrome and neurologic toxicities, which can lead to death. Despite the significant potential for adverse events, there is a marked interest in using these genetically modified cells to improve survival outcomes for patients with r/r disease and a poor prognosis.
Key Questions:
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Is tisagenlecleucel therapy effective for improving remission and survival in patients with r/r B-cell ALL and r/r DLBCL?
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How does tisagenlecleucel therapy compare with alternative treatments (e.g., chemotherapy, hematopoietic stem cell transplant [HSCT])?
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Is tisagenlecleucel therapy safe?
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Have specific patient selection criteria been identified for the use of tisagenlecleucel therapy for the treatment of ALL or DLBCL?
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