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FDA grants breakthrough designation to NiCord for bone marrow transplantation
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The FDA granted breakthrough therapy designation to the novel graft modality NiCord for bone marrow transplantation in patients with hematological malignancies, according to the modality’s manufacturer.
NiCord (Gamida Cell) — an ex vivo expanded cell graft that utilizes NAM platform technology (Gamida Cell) to expand cells from the umbilical cord blood — is in development as an alternative to a bone marrow transplant for patients who cannot find a donor with fully-matched tissue.
The pilot and phase 1/phase 2 studies of NiCord in patients with hematologic malignancies demonstrated an improvement in time to neutrophil engraftment over cord blood transplantation.
In addition, NiCord showed fewer infections, reduced length of hospitalization, quicker platelet engraftment and improved non-relapse mortality when compared to unmanipulated cord blood transplantation.
“We are very pleased the FDA has recognized the potential of NiCord to address the unmet clinical need in bone marrow transplantation,” Yael Margolin, PhD, president and CEO of Gamida Cell, said in a press release. “The breakthrough therapy designation creates the foundation for a joint and concerted effort between the FDA and Gamida Cell to bring this important therapy faster to patients. We look forward to continuing our close cooperation with the FDA and other regulatory agencies to a positive conclusion as we prepare for commercialization.”