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Remestemcel-L receives backing from the ODAC for the treatment of children with acute GvHD
By Claire Baker
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On August 13, 2020, the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug administration (FDA) deemed remestemcel-L safe and effective in pediatric patients with steroid refractory acute graft-versus-host disease (SR-aGvHD).
The ODAC voted nine to one for the approval of remestemcel-L—a decision largely based on the prospective MSB-GvHD001 study (NCT02336230), which met its primary endpoint. The FDA decision is expected by end of September 2020. Read the full study design, safety, and efficacy data on the GvHD Hub here.
Remestemcel-L is an investigational, off-the-shelf therapy that utilizes ex vivo-expanded adult mesenchymal stem cells derived from the bone marrow of an unrelated healthy donor. The GvHD Hub recently reported the Biologics License Application acceptance for remestemcel-L, which resulted in a Priority Review designation.
- U.S. Food and Drug Administration. ODAC Briefing Document: Session on clinical evidence (PM session). https://www.fda.gov/media/140986/download. August 13, 2020. Accessed August 14, 2020.
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