The FDA extended its review of Orca-T's Biologics License Application (BLA) by three months, moving the new PDUFA target action date to July 6, 20263
The extension followed Orca Bio's submission of updated chemistry, manufacturing and controls (CMC) information in response to FDA requests3
The FDA classified the submission as a Major Amendment (MA) to the BLA, which triggered the three-month review extension3
The FDA has not requested any additional clinical data3
Orca-T is an allogeneic T-cell immunotherapy for treating hematologic malignancies including acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes3
Orca Bio stated the updated information submitted in the amendment does not affect the benefit-risk conclusions of the BLA3
The original PDUFA target action date was April 6, 2026, which was subsequently extended to April 1, 2026, and then further extended to July 6, 20264
Sources:
3. https://www.morningstar.com/news/business-wire/20260401769347/orca-bio-announces-fda-review-extension-of-bla-for-orca-t-for-the-treatment-of-hematologic-malignancies
4. https://orcabio.com/orca-bio-announces-fda-acceptance-and-priority-review-of-the-biologics-license-application-bla-for-orca-t-to-treat-hematological-malignancies/