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Axicabtagene ciloleucel receives EC approval as a third-line treatment of follicular lymphoma
On June 28, 2022, it was announced that the European Commission (EC) has granted approval to axicabtagene ciloleucel (axi-cel), a CD19-directed chimeric antigen receptor T-cell product, for the treatment of relapsed or refractory follicular lymphoma in adult patients who have already received ≥3 lines of systemic therapy. The approval is based on key data obtained from the pivotal phase II ZUMA-5 trial (NCT03105336),1 previously reported on the Lymphoma Hub. The therapy has also been recently approved by the U.S. Food and Drug Administration (FDA) as a second-line treatment for adult patients with relapsed or refractory follicular lymphoma.
Efficacy1
- 91% overall response rate
- 77% complete response rate
- 56% of patients remained in response at the end of analysis (Month 24)
Safety1
- 6% of patients experienced Grade ≥3 cytokine release syndrome
- 16% of patients experienced neurologic events
- The most frequently reported adverse events were cytokine release syndrome (77%), infections (59%), and encephalopathy (47%)
References
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