Gamida Cell Begins BLA for Omidubicel

Gamida Cell has begun a rolling BLA submission for omidubicel, indicated for patients with blood cancers in need of stem cell transplant. The company says the submission should be completed before 6/30.

The BLA is based on data from a Phase 3 study showing that omidubicel achieved a statistically significant reduction in time to neutrophil engraftment, reduced hospitalization time, decreased risk of infection and shorter time to platelet engraftment, according to the company.

Gamida says there are about 1,000 patients each year who are deemed eligible for an allogeneic stem cell transplant but cannot find an appropriate donor. Because of its less stringent matching criteria, “omidubicel has the potential to improve outcomes for allogeneic stem cell transplant patients compared to other donor sources and expand access for patients who cannot find a suitable donor,” it says.