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# Fast Track for Nohla Therapeutics’ Dilanubicel
- URL: https://www.fdaweb.com/fast-track-for-nohla-therapeutics-dilanubicel/
- Published: 2018-08-06T12:00:00.000Z
- Updated: 2026-09-15T00:23:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142044

FDA has granted Nohla Therapeutics a fast track designation for dilanubicel (NLA101) for patients with high-risk hematologic malignancies receiving an allogeneic cord blood transplant. The designation was based on efficacy and safety data from a Phase 2 single arm study in patients with hematologic malignancies who underwent a myeloablative cord blood transplant. The results 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, the company says. In addition, dilanubicel-treated patients experienced no severe acute Graft-versus-Host Disease and no transplant-related mortality.

  
Dilanubicel is a universal donor, off-the-shelf, *ex vivo* expanded hematopoietic stem and progenitor cell investigational product intended to provide rapid, transient hematopoiesis with long-term immunologic benefits, Nohla says. Unlike autologous or patient-specific allogeneic cell therapies, dilanubicel does not require human leukocyte antigen tissue matching.