Phase 3 Study Shows Omidubicel Is Effective, Safe in Treatment of Patients With Hematologic Malignancies in Need of Bone Marrow Transplant

March 26, 2021

Mitchell Horwitz, MD, principal investigator and professor of medicine at the Duke Cancer Institute, discusses the results of a phase 3 study of omidubicel, which treats patients with hematologic malignancies in need of a bone marrow.

Pharmacy Times® interviewed Mitchell Horwitz, MD, principal investigator and professor of medicine at the Duke Cancer Institute, on the results of a phase 3 study of omidubicel, which treats patients with hematologic malignancies in need of a bone marrow transplant.

The results of the study were recently presented at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research meetings.

During the discussion, Horwitz addressed how a cell therapy treatment option will impact the treatment of patients with hematologic malignancies, what the results of the study demonstrated regarding the treatment, what the efficacy and safety results for omidubicel were, the impact omidubicel may have on the field of cell therapy, and the potential timeline of when omidubicel would be available.

Horwitz explained that the study sponsor (Gamida Cell) was currently working as quickly as possible to get the cell therapy to market, with the submission of a biologics license application (BLA) to the FDA planned for the second half of 2021.

“So hopefully by the summer or late summer, we'll have a better idea as to when this will be made available," Horwitz said.*

*Update: Gamida Cell has guided that the company expects to submit a BLA to the FDA in the fourth quarter of 2021.

Updated March 29, 2021