US FDA Questions Adequacy Of Mesoblast’s Remestemcel-L Single-Arm Study For Pediatric GVHD

 
• By Brenda Sandburg

In advisory committee briefing documents, agency also says critical quality attributes of the graft-versus-host disease treatment do not show a relationship with clinical potency and may not ensure control of clinical effectiveness of individual drug product lots.

Stem Cells Therapy Concept stem cell transplant through perfusion
FDA panel to vote on whether data support efficacy of remestemcel-L in pediatric patients with graft-versus-host disease • Source: Shutterstock

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