6 August 2018 - Nohla Therapeutics today announced that the U.S. FDA has granted fast track designation to dilanubicel (NLA101) for patients with high-risk haematologic malignancies receiving an allogeneic cord blood transplant. 

Dilanubicel has already received PRIME designation from the European Medicines Agency, and orphan drug designation from the FDA and European Commission.

The FDA Fast Track designation was supported by efficacy and safety data from a dilanubicel Phase 2 single arm study in patients with haematologic malignancies who underwent a myeloablative cord blood transplant. The results of this study demonstrated that infusion of dilanubicel was safe and led to faster neutrophil and platelet recovery with improved long-term survival when compared to a separate control group. In addition, dilanubicel-treated patients experienced no severe acute graft-versus-host disease and no transplant-related mortality.

Read Nohla Therapeutics press release