FDA grants priority review to Orca's hematological malignancy cell therapy

The U.S. FDA has accepted and granted priority review to Orca Bio’s BLA for Orca-T, its lead investigational allogeneic T-cell immunotherapy, for the treatment of hematological malignancies including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndromes (MDS).

The FDA granted the BLA a PDUFA target action date of April 6, 2026. If approved, Orca-T would be the first allogeneic T-cell immunotherapy for the treatment of hematological malignancies.

The BLA submission for Orca-T is supported by positive results from the pivotal phase 3 study that evaluated the safety, efficacy and tolerability of Orca-T compared to conventional allogeneic hematopoietic stem cell transplant (alloHSCT) in patients with AML, ALL and MDS. The study met its primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease with Orca-T versus alloHSCT.

Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. The therapy has received RMAT and orphan drug designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the FDA.