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Gamida Cell’s Omisirge (omidubicel-onlv) Receives the US FDA’s Approval for Hematologic Malignancies

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Gamida Cell’s Omisirge (omidubicel-onlv) Receives the US FDA’s Approval for Hematologic Malignancies

Shots:

  • The US FDA has approved Omisirge to reduce the risk of infection in children & adults aged ≥12yrs. with hematologic malignancies who have a planned umbilical cord blood transplantation after a myeloablative conditioning regimen
  • The approval was based on the P-III trial evaluating omidubicel vs transplantation of umbilical cord blood in 125 patients which showed that 87% of patients with Omisirge achieved neutrophil recovery with a median of 12 days vs 83% in the umbilical cord group with a median of 22 days
  • 39% vs 60% experienced a bacterial or fungal inf. within 100 days after transplantation. The safety profile was consistent with the expected AEs of Allo-HSCT, following myeloablative conditioning & the full results are available in Blood

Ref: BusinessWire | Image: Gamida Cell

Related News:- Gamida Cell Reports First Patient Dosing in P-I/II Study of GDA-201 for the Treatment of Follicular and Diffuse Large B Cell Lymphoma

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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