FDA extends review of Orca cell therapy for blood cancers

The U.S. FDA has extended the review timeline for Orca Bio’s BLA for Orca-T, a novel cell therapy for the treatment of patients with hematologic malignancies.

The PDUFA date was pushed by three months, making the new target action date July 6, 2026. If approved, Orca-T would be the first allogeneic T cell immunotherapy for the treatment of hematological malignancies.

The extension follows Orca Bio's recent submission of updated CMC information in response to requests from the FDA as part of the standard review process. The FDA classified the submission as a major amendment to the BLA. The agency has not requested any additional clinical data and Orca believes that the updated information submitted does not affect the benefit-risk conclusions of the BLA.

Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. It is composed of highly purified hematopoietic stem cells, regulatory T cells and conventional T cells derived from either related or unrelated matched donors. The therapy was granted priority review, RMAT and orphan drug designations by the FDA.