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# Priority Review for Orca Blood Cancer Cell Therapy
- URL: https://www.fdaweb.com/priority-review-for-orca-blood-cancer-cell-therapy/
- Published: 2025-10-06T12:00:00.000Z
- Updated: 2026-09-14T15:23:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159989

FDA has accepted for priority review an Orca Bio BLA for Orca-T, an investigational allogeneic T-cell immunotherapy for patients with acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes. The agency has set 4/6/2026 as the user fee review action target date. If approved, Orca-T would become the first allogeneic T-cell immunotherapy available for hematological malignancies, the company says.

The BLA is based on data from the Phase 3 Precision-T trial (NCT04013685), a randomized, open-label, multi-center study comparing Orca-T with conventional allogeneic hematopoietic stem cell transplant. The study met its primary endpoint, showing a statistically significant improvement in survival free of moderate-to-severe chronic graft-versus-host disease among patients treated with Orca-T, according to the company.

Orca Bio says Orca-T is composed of purified regulatory T cells, hematopoietic stem cells, and conventional T cells sourced from matched related or unrelated donors. The therapy is designed to restore healthy immune and blood systems while minimizing transplant-related complications. Orca-T has previously received regenerative medicine advanced therapy and orphan drug designation from FDA for preventing graft-versus-host disease or death in eligible transplant patients.