FDA Approves Expanded Indication to Tocilizumab-Anoh IV for CRS
The FDA expands tocilizumab-anoh's approval for treating cytokine release syndrome (CRS), enhancing treatment options for patients aged 2 and older. The FDA has approved the expanded indication of the intravenous (IV) formulation of tocilizumab-anoh (Avtozma; Celltrion Inc) to include treatment of cytokine release syndrome (CRS) in adult and pediatric patients aged 2 years and older.
Tocilizumab-anoh IV is now approved for all the same conditions as Actemra IV (tocilizumab; Roche, Genentech) in the US. Earlier this year, tocilizumab-anoh was initially approved as a biosimilar to Actemra for the treatment of rheumatoid arthritis (RA), giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.
"We are proud that tocilizumab-anoh IV has now achieved full indication alignment with the reference Actemra IV. This milestone marks an important step forward in our mission to deliver a safe and effective therapy for CRS," Thomas Nusbickel, chief commercial officer at Celltrion USA, said in a news release.
Cytokine Release Syndrome
CRS is caused when the immune system responds to infection or immunotherapy drugs more aggressively than it should, leading to the excessive release of cytokines into the bloodstream. Once the chemicals are released, individuals can experience symptoms of fever, nausea, fatigue, and body aches, which could range from mild and flu-like to severe and life-threatening. However, symptoms can vary depending on what body systems are impacted by CRS.
While treatment for CRS may vary, common therapies include IV fluids, drugs to reduce fever, oxygen, mechanical ventilation, blood transfusions, dialysis, electrolyte management, and heart medications. Typically, individuals that develop CRS from immunotherapy, such as CAR T-cell therapy, recover in about 1 to 2 weeks, but this depends on the severity.
As a recombinant humanized monoclonal antibody, tocilizumab-anoh works by blocking the IL-6 receptor. The approval was based on data from a phase 3 clinical trial that evaluated the biosimilar's efficacy, pharmacokinetics, safety, and immunogenicity when compared to the reference, Actemra, when coadministered with methotrexate for patients with moderate to severe active RA.
Individuals with RA who were aged 18 to 75 years old were included in the study and randomly assigned on day 1 to receive either the biosimilar or the European Union formulation of the reference product every 4 weeks until week 20. Following, individuals on the biosimilar continued with the same treatment every 4 weeks until week 48. Individuals who were on the reference product were then reassigned to either continue with the reference product or switch to the biosimilar every 3 weeks until week 48.
The primary goals of the study were to measure the mean change from the baseline in the Disease Activity Score-28 for RA with ESR (DAS28-ESR) at both week 12 and week 24. Other outcomes that were measured included changes from baseline in ESR, CRP, Simplified Disease Activity Index, and Clinical Disease Activity.
The results demonstrated that the study met its primary end point for DAS28-ESR change at weeks 12 and 24, with the biosimilar and the reference product showing similar improvements across all secondary outcomes.
With the expanded indications, the biosimilar now has similar indications to the reference product, providing treatment for CRS and various inflammatory conditions.
