Onco-Summaries: Daily Oncology Updates at a Glance

06/10/2025

Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies (Ref)

The US FDA accepted Orca Bio's BLA seeking approval for Orca-T (allogeneic T-cell immunotherapy) as a treatment for hematological malignancies including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes.

• Priority Review status has been granted with a PDUFA target action date of April 6, 2026

  
  

• The BLA submission was based on positive results from the Phase 3 Precision-T/NCT04013685 trial

AstraZeneca and Daiichi Sankyo's Datroway elicited significant OS and PFS benefit as a 1L treatment of TNBC (Ref)

The Phase 3 TROPION-Breast02 trial of AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Datroway; TROP2 ADC) elicited a statistically significant and clinically meaningful improvement in the dual primary endpoints of OS and PFS vs investigator's choice of chemotherapy as a first-line treatment for patients with locally recurrent, inoperable or metastatic, triple-negative breast cancer (TNBC) for whom immunotherapy was not an option.

• The safety profile was consistent with previous clinical trials in breast cancer

  
  

• The results will be presented at an upcoming medical meeting and shared with regulatory authorities