Mesoblast Plans Small Trial After Second CRL For GVHD Cell Therapy
Seeking approval for pediatric patients with acute graft-versus-host disease, Mesoblast gets a second US FDA complete response and now says it will seek to get needed data from a small trial in adults.
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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.
Keeping Track: Disappointment For Mesoblast And Aquestive; Opdivo/Yervoy Add Mesothelioma Claim; Pediatric Approvals
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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.