Posted by Michael Wonder on 07 Oct 2025
Orca Bio announces FDA acceptance and priority review of the biologics license application for Orca-T to treat haematological malignancies
6 October 2025 - FDA assigns PDUFA target action date of April 6, 2026.
Orca Bio today announced the US FDA has accepted for Priority Review the Biologics License Application seeking approval for Orca-T, its lead investigational allogeneic T-cell immunotherapy, for the treatment of haematological malignancies including acute myeloid leukAemia, acute lymphoblastic leukAemia and myelodysplastic syndromes.
