Posted by Michael Wonder on 07 Mar 2017
FDA grants fast track designation for Mesoblast's cell therapy in children with acute graft versus host disease
7 March 2017 - Mesoblast today announced that the US FDA has granted a fast track designation for the use of its cell therapy, MSC-100-IV, to achieve improved overall response rate in children with steroid refractory acute graft versus host disease (aGVHD).
Mesoblast’s application for fast track status was supported by the clinical data in 241 paediatric patients with steroid refractory aGVHD who were treated on a single expanded access protocol with MSC-100-IV. Overall response rate at day 28 in this group was 65%, and day 100 survival was significantly improved in children who achieved an overall response at day 28 (82% vs. 39%, log rank p-value <0.0001).
