NasdaqGS:ONCBiotechs
Will FDA Priority Review And Breakthrough Status For TEVIMBRA Combo Reshape BeOne Medicines' (ONC) Narrative
In April 2026, BeOne Medicines reported that the FDA granted Priority Review to its sBLA for TEVIMBRA plus ZIIHERA and chemotherapy, and Breakthrough Therapy Designation for ZIIHERA-based regimens, for first-line treatment of unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma.
The Phase 3 HERIZON-GEA-01 trial underpinning these filings showed statistically significant gains in overall and progression-free survival versus...