Axi-Cel Indications Updated to Include Cytokine Release Syndrome Prophylaxis

By Sabrina Ahle - Last Updated: February 8, 2022

The US Food and Drug Administration (FDA) has approved an update to the prescribing information for all approved indications of axicabtagene ciloleucel (axi-cel) to include the use of prophylactic corticosteroids in managing side effects. Axi-cel is a CD19-directed chimeric antigen receptor T-cell immunotherapy.

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A new cohort of the ZUMA-1 trial was designed to assess the safety and efficacy of corticosteroids for the prevention of cytokine release syndrome (CRS) and neurologic events in patients with relapsed or refractory large B-cell lymphoma. Patients in the study received dexamethasone 10 mg orally once daily for 3 days prior to axi-cel infusion. In the new cohort, patients received corticosteroids and tocilizumab earlier and received 3 prophylactic doses.

Among the 39 patients in this cohort, no grade ≥3 CRS events were reported, compared with 13% of patients in other cohorts (n, 14/108). Grade ≥3 neurologic events were reported in 13% of patients (n, 5) in the prophylaxis cohort, while 31% of patients in other cohorts (n, 33) experienced grade ≥3 neurologic events. In the prophylaxis cohort, the median times to CRS and neurotoxicity onset were 5 days (range, 1-15) and 6 days (range, 1-274), respectively.

“The label update may help physicians manage potential complications and determine appropriate setting for care of their patients,” Gilead, the manufacturer of axi-cel, stated in a press release.

Source: Gilead press release, Jan. 31, 2022.

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