FDA Greenlights Label Update for Use of Steroids Following Axi-Cel for Management of CRS


A label update for the CAR T-cell therapy product axicabtagene ciloleucel has been approved by the FDA to allow for use of prophylactic corticosteroid to manage cytokine release syndrome.

The FDA has approved a label update to prescribing information for axicabtagene ciloleucel (axi-cel; Yescarta) to include the use of corticosteroids for the prevention of cytokine release syndrome (CRS), according to a press release from Kite. This will be applied across all approved indications for axi-cel.1

The update was based on findings from a safety management cohort of the phase 1/2 ZUMA-1 study (NCT02348216), which assessed the use of axi-cel in patients with large B-cell lymphoma.2 The purpose of the safety management cohort, or cohort 6, was to examine how the use of prophylactic corticosteroids and earlier treatment with corticosteroids and/or tocilizumab (Actemra) and prophylactic levetiracetam (Spritam) might impact the occurrence and severity of CRS and neurotoxicity.

“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, said in a press release. “Since the first approval of [axi-cel], 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[-cell] therapies.”

At the time of cut-off, those in cohort 6 who received treatment with corticosteroids did not experience any grade 3 or higher neurologic events vs 13% of patients in cohorts 1 and 2. Notably, cohort 6 was not designed to provide statistical comparison with cohorts 1 and 2, as they were unbalanced. Investigators reported a median time to onset of 5.0 days (range, 1-15) in cohort 6. Moreover, the median time to onset of neurotoxicity was 6.0 days (range, 2-162).

Investigators reported that 68% of patients did not experience neurotoxicity or CRS 72 hours after undergoing infusion.

The median cumulative dose of corticosteroids including prophylactic use (n = 40) was 1252 mg. A total of 15 patients received prophylactic corticosteroids only with no additional corticosteroids used for the management of other adverse effects.

Patients who received corticosteroid prophylaxis achieved an overall response rate (ORR) of 100% and a complete response (CR) rate of 73%. Moreover, in patients treated with corticosteroids for prophylaxis and toxicity management had ORR and CR rates of 92% and 84%, respectively.


  1. U.S. FDA approves new label update for CAR T-cell therapy Yescarta® showing prophylactic steroid use improves management of cytokine release syndrome. News release. Kite. January 31, 2022. Accessed January 31, 2022. https://bit.ly/3AJRmgd
  2. Oluwole OO, Bouabdallah K, Muñoz J, et al. Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma. Br J Haematol. 2021;194(4):690-700. doi:10.1111/bjh.17527
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