The FDA approved axicabtagene ciloleucel for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma.
The FDA previously approved axicabtagene ciloleucel for adults with relapsed or refractory LBCL or follicular lymphoma who received two or more lines of systemic therapy.
The latest approval was based on results from the randomized, open-label, multicenter ZUMA-7 trial, which included 359 adult patients with primary refractory LBCL or those who had relapsed within 12 months following completion of first-line therapy. Patients had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous hematopoietic cell transplantation (AHCT).
Patients were randomized 1:1 to receive 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 AHCT in patients who reached complete or partial remission.
Event-free survival (EFS; primary efficacy measure) was significantly longer in the axicabtagene ciloleucel arm (hazard ratio=0.40; 95% CI, 0.31-0.51; P<.0001). The estimated 18-month EFS rate was 41.5% (95% CI, 34.2-48.6) in the axicabtagene ciloleucel arm and 17.0% (95% CI, 11.8-23.0) in the standard therapy group. Estimated median EFS was 8.3 months and 2.0 months, respectively.
Axicabtagene ciloleucel has a boxed warning for cytokine release syndrome and neurologic toxicities.
Source: FDA press release, April 2022
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