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FDA Grants Remestemcel-L Priority Review for Pediatric GVHD

Jason M. Broderick @jasoncology
Published: Wednesday, Apr 01, 2020

The FDA has granted remestemcel-L (Ryoncil) a priority review designation for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD), according to Mesoblast Limited, the manufacturer of the allogeneic cell therapy.1

Beyond GVHD, remestemcel-L is also being explored as a treatment for advanced heart failure and chronic low back pain.

References           

  1. FDA ACCEPTS MESOBLAST’S BIOLOGICS LICENCE APPLICATION FOR RYONCIL AND AGREES TO PRIORITY REVIEW. Published April 1, 2020. https://yhoo.it/2JBXrRP. Accessed April 1, 2020.           
  2. Kurtzberg J, Prockop S, Chaudhury S, et al. Study 275: updated expanded access program for remestemcel-L in steroid-refractory acute graft-versus-host disease in children [published online February 7, 2020]. Biol Blood Marrow Transplant. pii: S1083-8791(20)30059-8. doi: 10.1016/j.bbmt.2020.01.026

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