FDA approval of axicabtagene ciloleucel for patients with R/R follicular lymphoma

On March 5, 2021, it was announced that the U.S. Food and Drug Administration (FDA) approved the use of axicabtagene ciloleucel, a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma who have had ≥ 2 lines of therapy.¹ This accelerated approval was based on the results of the ZUMA-5 study (NCT03105336), previously reported on the Lymphoma Hub.

Axicabtagene ciloleucel¹

• An anti-CD19 autologous CAR T-cell therapy.
• Previously approved for adults with R/R large B-cell lymphoma who have received ≥ 2 lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and diffuse large B-cell lymphoma arising from follicular lymphoma.

ZUMA-5 (NCT03105336)¹

• An ongoing, single-arm, open-label, multicenter trial in 146 patients (≥ 18 years old) with R/R indolent non-Hodgkin lymphoma, who received ≥ 2 prior lines of systemic therapy.
• In total, 91% of patients with R/R follicular lymphoma (n = 81) responded to a single infusion of axicabtagene ciloleucel, with an estimated 74% of patients in continued remission at 18 months.
• With a follow-up of 14.5 months, the median duration of response was not yet reached.
• Safety analysis (n = 146) showed Grade ≥ 3 cytokine release syndrome in 8% of patients and neurologic toxicities in 21% of patients.
• The most common Grade ≥ 3 adverse reactions (in ≥ 10% of patients) included febrile neutropenia, encephalopathy, and infections with pathogen unspecified.