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.
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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.
US FDA Questions Adequacy Of Mesoblast’s Remestemcel-L Single-Arm Study For Pediatric GVHD
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.
US FDA, Sponsors Eye Best Practices For Virtual AdComms
Agency has created a centralized team to help review divisions with virtual advisory committee preparations and is trying to notify sponsors earlier in the review process about the need for a panel; sponsors cite importance of having a back channel of communications so team members can communicate with each other while an AdComm is underway.