US FDA Again Asked To Hold Off On Approval Of Ryoncil Pediatric Cell Therapy
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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Mesoblast Still Hopes To Show Utility Of Allogeneic Stem Cell Therapy In COVID-19
Although its 300-patient, Phase III trial is not likely to reduce mortality, Australian firm says the full dataset may show potential for off-the-shelf cell therapy in acute respiratory distress syndrome.
Mesoblast’s Cell Therapy For Pediatric GVHD Gets US Panel Green Light Despite FDA's "Substantial Concerns"
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.
Ahead Of Ryoncil’s Advisory Committee, Citizen Petition Opposes Approval For Pediatric GVHD
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.