Despite questions raised by the US Food and Drug Administration, an advisory committee voted 8 to 2 that the available data support the efficacy of Mesoblast Limited’s remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD).
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.
