Guess the Therapy Answer April 22, 2026
Which Orca Bio allogeneic cell therapy has a BLA currently under review by the FDA for various hematologic malignancies?
Answer: Orca-T.
See below for further reading on Orca-T:
April 8, 2026 — The FDA’s Prescription Drug User Fee Act (PDUFA) target action date for Orca Bio’s biologics license application (BLA) for Orca-T, an investigational allogeneic cell therapy product intended to treat various hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndromes (MDS), has been pushed back to July 6, 2026. The FDA extended the review timeline after the company submitted updated chemistry, manufacturing and controls (CMC) information to accommodate FDA requests, considering the CMC information submission a Major Amendment. The PDUFA action date for the BLA had originally been set at April 6, 2026, when the FDA first accepted the BLA.
October 7, 2025 — Orca Bio’s BLA for Orca-T, an investigational allogeneic cell therapy product intended to treat various hematologic malignancies, including AML, ALL, and MDS, has been accepted by the FDA with priority review.
The PDUFA target action date for the BLA has been set for April 6, 2026. The BLA is supported by data from an open-label, randomized phase 3 clinical trial (Precision-T; NCT05316701). The pivotal, multicenter Precision-T study is evaluating Orca-T against conventional allogeneic hematopoietic stem cell transplant (allo-HSCT) for the treatment of AML, ALL, and MDS. Notably, patients treated with Orca-T showed a statistically significant improvement in survival free of moderate to severe chronic graft-vs-host disease (GVHD) compared with patients treated with allo-HSCT, and as such, Precision-T met its primary end point.
"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,” Nate Fernhoff, PhD, the cofounder and CEO of Orca Bio, said in a statement. “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. Supported by positive phase 3 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.”
