FDA Approves Label Update for Axicabtagene Ciloleucel for Improved Management of Cytokine Release Syndrome

The FDA has approved an update to the prescribing information for axicabtagene ciloleucel (Yescarta, Gilead) to include use of prophylactic corticosteroids across all approved indications. Axicabtagene ciloleucel is the first and only chimeric antigen receptor (CAR) T-cell therapy with information in the label to help physicians manage and potentially prevent treatment-related adverse effects (AEs), according to a Gilead press release.

The update is based on the results of a new safety management cohort of the ZUMA-1 study, which was designed to assess the impact of prophylactic use of corticosteroids and earlier treatment with corticosteroids and/or tocilizumab and prophylactic levetiracetam on the incidence and severity of cytokine release syndrome (CRS) and neurologic events.

Additional data showed that 68% of patients had no CRS or neurologic events within 72 hours of axicabtagene ciloleucel infusion. Further, the 1-year update suggests that Cohort 6 toxicity management strategy can improve certain AEs without compromising the activity of axicabtagene ciloleucel.

“These new data will enable doctors to more easily and confidently manage treatment for patients,” said Frank Neumann, MD, PhD, Kite’s global head of Clinical Development, in the 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. Our responsibility includes research to expand into new diseases and earlier lines of treatment, but also continuously improving the efficacy and safety of our existing CAR T therapies.”

The ZUMA-1 study also included Cohort 4, which was added to the FDA label in May 2021 and evaluated earlier treatment with corticosteroids and/or tocilizumab and prophylactic levetiracetam. Cohort 6 builds on this research by evaluating dexamethasone 10 mg orally once daily for 3 days starting prior to axicabtagene ciloleucel infusion, according to the press release.

Axicabtagene ciloleucel was the first CAR T-cell therapy to be approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.

REFERENCE

U.S. FDA approves new label update for CAR T-cell therapy Yescarta® showing prophylactic steriod use improves management of cytokine release syndrome. Gilead. January 31, 2022. Accessed January 31, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/1/us-fda-approves-new-label-update-for-car-tcell-therapy-yescarta-showing-prophylactic-steriod-use-improves-management-of-cytokine-release-syndrome