Orca Bio has announced that the US FDA extended the review timeline for its Biologics License Application (BLA) for Orca-T, an investigational allogeneic T-cell immunotherapy targeting hematologic malignancies including acute leukemias and myelodysplastic syndromes. The revised PDUFA target action date is July 6, 2026, three months beyond the original deadline, following the FDA's classification of a recent company submission as a Major Amendment to the BLA.
The extension was triggered by Orca Bio's submission of updated chemistry, manufacturing and controls (CMC) information provided in response to FDA requests during the standard review process, the company said. The agency has not requested additional clinical data, and Orca Bio stated it believes the updated CMC information does not affect the benefit-risk conclusions of the BLA. The filing carries Priority Review designation, and Orca-T has previously received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft-versus-host disease (GVHD) or death in patients eligible for hematopoietic stem cell transplant (HSCT).
Orca-T is composed of highly purified hematopoietic stem cells, regulatory T-cells, and conventional T-cells derived from matched related or unrelated donors. The inclusion of regulatory T-cells is central to the product's design rationale: by modulating the post-transplant alloreactive immune response, the approach aims to reduce GVHD without eliminating the graft-versus-leukemia effect that makes allogeneic transplantation therapeutically relevant. This positions Orca-T not as an adjunctive drug but as a redefined graft — intended to replace conventional unmanipulated cell products at the transplant step itself.