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%)