Ahead Of Ryoncil’s Advisory Committee, Citizen Petition Opposes Approval For Pediatric GVHD
Executive Summary
Lawyer asks US FDA to require another trial before licensing Mesoblast’s stem cell therapy for children with SR-aGVHD; Incyte’s Jakafi is only product approved for the indication.
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Attorney says new information Mesoblast submitted following ‘complete response’ letter does not include data from randomized controlled trial, which he says is needed to provide substantial evidence of efficacy in treatment of children with graft-versus-host disease.
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