- Today
- Holidays
- Birthdays
- Reminders
- Cities
- Atlanta
- Austin
- Baltimore
- Berwyn
- Beverly Hills
- Birmingham
- Boston
- Brooklyn
- Buffalo
- Charlotte
- Chicago
- Cincinnati
- Cleveland
- Columbus
- Dallas
- Denver
- Detroit
- Fort Worth
- Houston
- Indianapolis
- Knoxville
- Las Vegas
- Los Angeles
- Louisville
- Madison
- Memphis
- Miami
- Milwaukee
- Minneapolis
- Nashville
- New Orleans
- New York
- Omaha
- Orlando
- Philadelphia
- Phoenix
- Pittsburgh
- Portland
- Raleigh
- Richmond
- Rutherford
- Sacramento
- Salt Lake City
- San Antonio
- San Diego
- San Francisco
- San Jose
- Seattle
- Tampa
- Tucson
- Washington
Orca Bio Announces FDA Review Extension for Orca-T Blood Cancer Treatment
New PDUFA target date of July 6, 2026 allows additional time for FDA review.
Apr. 2, 2026 at 6:26am
Got story updates? Submit your updates here. ›
Orca Bio, a late-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of its Biologics License Application (BLA) for Orca-T, an investigational allogeneic T-cell immunotherapy for the treatment of hematologic malignancies. The new Prescription Drug User Fee Act (PDUFA) target action date is July 6, 2026.
Why it matters
The extension follows Orca Bio's submission of updated chemistry, manufacturing and controls (CMC) information in response to FDA requests. While the review timeline has been extended, the FDA has not requested any additional clinical data, indicating that the updated information does not affect the benefit-risk conclusions of the BLA. This extension allows the FDA additional time to complete its review of Orca-T, which has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designations.
The details
Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies, including acute leukemias and myelodysplastic syndromes. The therapy is composed of highly purified hematopoietic stem cells, regulatory T-cells and conventional T-cells derived from either related or unrelated matched donors.
- The BLA for Orca-T was granted Priority Review by the FDA.
- Orca-T previously received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation.
- The new PDUFA target action date is July 6, 2026.
The players
Orca Bio
A late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy.
Nate Fernhoff
Co-founder and chief executive officer at Orca Bio.
U.S. Food and Drug Administration (FDA)
The regulatory agency that is reviewing the Biologics License Application (BLA) for Orca-T.
What they’re saying
“We appreciate the frequent engagement with the FDA throughout the review process. Our continued focus is on preparing for the potential approval and commercial launch of Orca-T. We remain committed to working with the Agency, physicians and the broader blood cancer community to deliver this important therapy to patients with hematologic malignancies as quickly as possible.”
— Nate Fernhoff, Co-founder and chief executive officer at Orca Bio
What’s next
The FDA has not requested any additional clinical data, and Orca Bio believes the updated information submitted in the amendment does not affect the benefit-risk conclusions of the BLA. The company remains focused on preparing for the potential approval and commercial launch of Orca-T.
The takeaway
This extension allows the FDA additional time to complete its review of Orca-T, a potentially transformative cell therapy for patients with hematologic malignancies. The continued engagement between Orca Bio and the FDA, as well as the designations Orca-T has received, suggest the therapy may offer a new treatment option for those battling blood cancers.
