Orca Bio, a late-stage biotechnology company focused on high-precision cell therapy, has announced that the US FDA has extended the review of its Biologics License Application (BLA) for Orca-T, a treatment for hematologic malignancies. 

 

The new Prescription Drug User Fee Act (PDUFA) target action date is July 6, 2026.

 

The extension comes after Orca Bio submitted updated chemistry, manufacturing, and controls (CMC) data in response to FDA requests. The agency classified the submission as a Major Amendment, which adds three months to the review timeline. Crucially, the FDA has not requested additional clinical data, and Orca Bio says the new information does not affect the BLA’s benefit-risk conclusions.

 

“We appreciate the frequent engagement with the FDA throughout the review process,” said Nate Fernhoff, co-founder and chief executive officer at Orca Bio. “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.”

 

Orca-T’s BLA was granted Priority Review and has previously received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation.