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news.The US Food and Drug Administration (FDA) has accepted priority review of Biologics Licence Application (BLA) for Orca Bio’s lead investigational allogeneic T-cell immunotherapy Orca-T.
The Biologics License Application (BLA) is underpinned by positive findings from the pivotal Phase III trial, Precision-T. Credit: Chromatograph on Unsplash.com.
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Orca-T is being assessed to treat hematological malignancies, including myelodysplastic syndromes (MDS), acute myeloid leukaemia (AML), and acute lymphoblastic leukaemia (ALL).
The FDA has granted priority review, with a target action date under the Prescription Drug User Fee Act (PDUFA) set for 6 April 2026.
The BLA is underpinned by positive findings from the pivotal Phase III trial, Precision-T (NCT04013685).
Orca Bio co-founder and CEO Nate Fernhoff said: “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 graft versus host disease.
“Supported by positive Phase III clinical data, today’s regulatory milestone reflects important recognition of the transformative potential of Orca-T. We look forward to working collaboratively with the FDA on the review of our application with the goal of advancing Orca-T and making it available to patients in need.”
The Precision-T randomised, open-label, multi-centre trial evaluated the tolerability, safety, and efficacy of Orca-T in comparison to conventional allogeneic hematopoietic stem cell transplantation (alloHSCT) in subjects diagnosed with MDS, AML and ALL.
The study achieved its primary endpoint, demonstrating a statistically significant improvement in survival without moderate-to-severe chronic graft versus host disease (cGvHD) when comparing Orca-T to alloHSCT.
Orca-T consists of highly purified regulatory T cells, haematopoietic stem cells, and conventional T cells, all obtained from the peripheral blood of either unrelated or related matched donors.
