FDA
Avtozma now approved for cytokine release syndrome
FDA approved an expanded indication of the IV formulation of Avtozma (tocilizumab-anoh) to include the treatment of CAR T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients ≥2 years of age.
In January 2025, FDA approved Avtozma as a biosimilar to Actemra in IV formulations for the treatment of multiple conditions including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and COVID-19.
Efficacy
The efficacy of tocilizumab for the treatment of CRS was assessed in a retrospective analysis of pooled outcome data from clinical trials of CAR T-tell therapies for hematological malignancies. The study population included 24 males and 21 females of median age 12 years. Median time from start of CRS to first dose of tocilizumab was 4 days (range, 0-18 days). CRS resolution was defined as lack of fever and off vasopressors for ≥24 hours. Patients were considered responders if CRS resolved within 14 days of the first dose of tocilizumab, if no more than 2 doses of tocilizumab were needed, and if no other drugs other than tocilizumab and corticosteroids were used for treatment. Response rate was 69%. Achievement of CRS resolution within 14 days was confirmed in a second study using an independent cohort that include 15 patients with CAR T cell-induced CRS.
Sources:
Avtozma (tocilizumab-anoh) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761420s001lbledt.pdf Revised July 2025. Accessed August 10, 2025.
FDA approves expanded indication for Avtozma® (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS). [News release]. 2025. https://www.celltrion.com/en-us/company/media-center/press-release/4098