Mesoblast’s Cell Therapy For Pediatric GVHD Gets US Panel Green Light Despite FDA's "Substantial Concerns"

 
• By Brenda Sandburg

Oncologic Drugs Advisory Committee votes 8-2 that data support efficacy of the product, which could be the first mesenchymal stem cell product to clear the agency. FDA's concerns include reliance on a pivotal Phase III single-arm study.

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Mesoblast's remestemcel-L data is sufficient to support efficacy, FDA panel concludes • Source: Shutterstock

Despite questions raised by the US Food and Drug Administration, an advisory committee voted 8 to 2 that the available data support the efficacy of Mesoblast Limited’s remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD).

In opening the 13 August virtual meeting of the Oncologic Drugs Advisory Committee, FDA’s Wilson Bryan, director of the Office...

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