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Axicabtagene Ciloleucel Receives FDA Approval in Large B-Cell Lymphoma

By: Lauren Velentzas
Posted: Tuesday, April 5, 2022

On April 1, the U.S. Food and Drug Administration (FDA) approved the chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel for the second-line treatment of patients with relapsed of refractory large B-cell lymphoma (LBCL). The National Comprehensive Cancer Network has also recently added axicabtagene ciloleucel to its Clinical Practice Guidelines in Oncology for B-Cell Lymphomas as a category 1 recommendation for diffuse large B-cell lymphoma.

These decisions were based on the results of the randomized, open-label, multicenter, ZUMA-7 trial. The trial comprised 359 adults with primary refractory LBCL or relapse within 12 months following completion of first-line therapy; they received a single infusion of axicabtagene ciloleucel following fludarabine and cyclophosphamide lymphodepleting chemotherapy or second-line standard therapy consisting of two or three cycles of chemoimmunotherapy, followed by high-dose therapy and autologous hematopoietic stem cell transplantation in patients who attained complete remission or partial remission, at a ratio of 1:1.

Patients who received axicabtagene ciloleucel demonstrated an increase in event-free survival, with a hazard ratio of 0.40 (95% confidence interval [CI] = 0.31–0.51, stratified P < .0001). The estimated 18-month event-free survival was 41.5% (95% CI = 34.2%–48.6%) with axicabtagene ciloleucel and 17.0% (95% CI = 11.8%–23.0%) with standard therapy. The estimated median event-free survival was 8.3 months (95% CI = 4.5–15.8 months) and 2.0 months (95% CI = 1.6–2.8 months), respectively.

The recommended dose is 2 × 106 CAR-positive viable T cells per kg of body weight, with a maximum of 2 × 108 CAR-positive viable T cells. Common adverse reactions (incidence ≥ 30%) include cytokine-release syndrome, fever, hypotension, encephalopathy, fatigue, tachycardia, headache, nausea, febrile neutropenia, diarrhea, musculoskeletal pain, infections with pathogen unspecified, chills, and decreased appetite.


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