FDA Approval Insights: Omidubicel in Blood Cancers Requiring Transplant


Dr Horwitz discusses the FDA approval of omidubicel in patients with blood cancers, key efficacy and safety data from the pivotal phase 3 trial, and the benefits omidubicel provides beyond improved neutrophil engraftment.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Mitchell E. Horwitz, MD, who joined us to talk about the FDA approval of omidubicel-onlv (Omisirge) in patients with blood cancers. Dr Horwitz is a member and a professor of medicine, hematologic malignancies, and cellular therapy at the Duke Cancer Institute, as well as an affiliate of the Duke Regeneration Center in Durham, North Carolina.

On April 17, 2023, the FDA approved the donor cord blood-based therapy omidubicel in adult and pediatric patients at least 12 years of age who have blood cancers for which they have previously received a myeloablative conditioning regimen and are planned to receive umbilical cord blood transplantation. This regulatory decision was supported by findings from a phase 3 trial (NCT02730299), in which 87% of the patients who received the agent achieved neutrophil recovery at a median of 12 days post-infusion. Conversely, in this trial, 83% of the patients who received standard-of-care umbilical cord blood transplantation achieved neutrophil recovery at a median of 22 days post-transplant.

In our exclusive interview, Dr Horwitz discussed the significance of this approval, key efficacy and safety data from the pivotal phase 3 trial, and the benefits omidubicel provides in this patient population beyond improved neutrophil engraftment.


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