The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) seeking approval for Orca-T, an investigational allogeneic T-cell immunotherapy for patients with hematological malignancies including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndromes (MDS).
The therapy was developed by OrcaBio; the Prescription Drug User Fee Act (PDUFA) target action date is April 6, 2026.
The BLA is supported by results from the phase 3 Precision-T study (NCT04013685), which evaluated Orca-T versus conventional allogeneic hematopoietic stem cell transplant in patients with AML, ALL, and MDS at high risk for poor outcomes. The study met its primary endpoint, according to the press release from the company.
In an oral abstract presented at the 51st Annual Meeting of the EBMT, held in Florence, Italy, investigators reported that Orca-T led to better outcomes than standard treatment for patients with blood cancers receiving myeloablative transplants from matched donors by reducing chronic graft-versus-host disease (GVHD) and improving survival compared to conventional allograft with tacrolimus/methotrexate.
“A stem cell transplant has been the only potentially curative option for many people with AML, ALL or MDS, however treatment-related toxicities too often hinder patient recovery. Acceptance of the Orca-T BLA marks a pivotal moment in our ability to deliver a first-in-class therapy designed to improve survival free from complications like [GVHD],” said Nate Fernhoff, PhD, co-founder and CEO at Orca Bio.
