Gamida Cell receives Breakthrough Therapy Designation from FDA
pharmafile | October 12, 2016 | News story | Research and Development | Breakthrough Therapy Designation, FDA, Gamida Cell, leukaemia, lymphoma
Gamida Cell have been granted a Breakthrough Therapy Designation for their NiCord drug. NiCord has already passed through Phase I and II trials, which showed the drug to be superior to cord blood transplantation. The drug has been developed as novel graft modality for bone marrow transplantation in patients with high risk haematological malignancies (blood cancers), such as leukaemia and lymphoma.
Breakthrough Therapy Designation is awarded to a drug that alone, or in combination with one or more drugs, could potentially treat a serious or life threatening disease or condition. This must be coupled with preliminary clinical evidence indicating that the drug could demonstrate substantial improvement over existing therapies, on one or more significant endpoints. With this status granted to NiCord, the FDA will act to expedite the development and review of the drug.
Gamida Cell plans to begin Phase III trials by the end of the year. The results from the Phase I and II trials displayed that NiCord demonstrated ‘clinically meaningful’ improvement in time to neutrophil engraftment over cord blood, with fewer infections, reduced length of hospitalisation, quicker platelet engraftment and improved non-relapse mortality in comparison 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,” commented Dr. Yael Margolin, president and CEO of Gamida Cell, upon the news of the designation. “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.”
Ben Hargreaves
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