Axi-Cel Indications Updated to Include Cytokine Release Syndrome Prophylaxis

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.

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.