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 6 April 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.
