Priority review for Gamida's cell therapy; PhIII shuttered at Akari; Immutep drops data on LAG3 study
Eight weeks after completing the rolling BLA for its blood cancer stem cell therapy, Gamida Cell says the FDA has accepted it for priority review.
The agency will make a decision on omidubicel by Jan. 30 of next year, the Boston-based biotech said Monday morning. The cell therapy is being evaluated as an allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers.
An advisory committee meeting is not expected, the company said. The FDA has previously tagged the cell therapy with breakthrough therapy and orphan drug designations.
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