Al-Ola A Abdallah: FDA Expands AVTOZMA Approval for Cytokine Release Syndrome
Al-Ola A Abdallah, Associate Professor and Plasma Cell Disorder Program Director of the Division of HMCT at the University of Kansas Medical Center, shared a post on X:
“FDA approves expanded indication for AVTOZMA (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS):
FDA UPDATE
The FDA has approved an expanded indication for intravenous tocilizumab-anoh (Avtozma; CT-P47), a biosimilar of tocilizumab (Actemra), for treating CRS.
With this approval, IV tocilizumab-anoh is now fully aligned with all US-approved indications of its reference drug, Actemra. A big win for biosimilar access!
Launch Date: IV tocilizumab-anoh is expected to hit the US market on August 31, 2025.
Tocilizumab-anoh is a recombinant humanized monoclonal antibody that blocks IL-6 receptors — a key target in inflammatory diseases like RA and CRS.
FDA’s original approval (Jan 2025):
- IV and subQ use
- Approved for:
- Rheumatoid arthritis
- Giant cell arteritis
- Juvenile idiopathic arthritis
- COVID-19
- Based on Phase 3 data.
Trial Insights (NCT05489224):
Primary endpoint met: Δ in DAS28-ESR at 24 weeks
No major differences in:
- Efficacy
- Safety
- Immunogenicity.
Formulations:
IV and Subcutaneous = More flexibility for providers and patients. Celltrion aims to expand immunology options with this dual approach.
Safety Notice: Watch for serious infections
Other risks: GI perforation, hepatotoxicity, lab changes, demyelinating disorders.”
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