FDA updates Yescarta label to include use of prophylactic steroids for toxicity management
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The FDA updated the prescribing information for axicabtagene ciloleucel to allow the use of prophylactic corticosteroids to manage the severity of certain treatment-related adverse events.
Axicabtagene ciloleucel (Yescarta; Kite Pharma, Gilead Sciences) — an autologous, gene-edited, CD19-directed chimeric antigen receptor T-cell therapy — is approved for use by adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma who received two or more lines of systemic therapy.
The label change provides guidance to prescribing physicians on the use of prophylactic corticosteroids to limit the incidence and severity of cytokine release syndrome and neurotoxicity, two of the more common severe treatment-related adverse events associated with CAR-T that require post-infusion monitoring.
“Consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient,” the revised prescribing information for Yescarta advised.
The FDA based the label change on results from a safety-expansion cohort in the ZUMA-1 study (cohort 6) designed to evaluate certain prophylactic agents — including corticosteroids — for the management of treatment-related toxicities and their impact on safety and efficacy.
None of the 39 patients in the safety-expansion cohort experienced grade 3 or greater CRS compared with 13% among the other treatment cohorts. Similarly, 13% of patients in the safety-expansion cohort had grade 3 or greater neurotoxicity compared with 31% in other study cohorts.
Additional data from the ZUMA-1 study presented in December at ASH Annual Meeting and Exposition indicated that prophylactic management used in the safety-expansion cohort did not impact treatment efficacy.
“These new data will enable doctors to more easily and confidently manage treatment for patients,” Frank Neumann, MD, PhD, global head of clinical development at Kite Pharma, said in a company-issued press release. “Since the first approval of Yescarta, Kite has worked closely with physicians to optimize all aspects of CAR T-cell therapy to enable as many patients as possible to have the chance to benefit from this treatment.”
References:
Oluwole OO, et al. Abstract 2832. Presented at: ASH Annual Meeting and Exposition; Dec. 11-14, 2021; Atlanta.
Yescarta (prescribing information). Santa Monica, CA: Kite Pharma, Inc.; 2022.
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