BeOne: FDA grants Priority Review to TEVIMBRA sBLA in 1L HER2+ GEA

FDA granted Priority Review to the sBLA for TEVIMBRA plus ZIIHERA and chemotherapy in first-line HER2+ gastroesophageal adenocarcinoma. The agency also granted Breakthrough Therapy Designation to the ZIIHERA + chemotherapy regimen (with or without TEVIMBRA). The filing is supported by the first interim analysis of the Phase 3 HERIZON-GEA-01 trial showing statistically significant OS and PFS improvements.

Key facts

Filed: Apr 29, 2026, 10:00 AM
Event: FDA designation
Direction: Positive
Company: ONCBeOne Medicines
Asset: zanidatamab
Source: Company press release
Confidence: Sourced
median OS: 26.4 months (TEVIMBRA + ZIIHERA + chemo) vs 24.4 months (ZIIHERA + chemo) vs 19.2 months (trastuzumab + chemo)
median PFS: 12.4 months vs 8.1 months

Source excerpt

U.S. FDA Grants Priority Review to BeOne Medicines' TEVIMBRA in First-Line HER2+ GEA U.S. FDA Grants Priority Review to BeOne Medicines' TEVIMBRA in First-Line HER2+ GEA U.S. FDA Grants Priority Review to BeOne Medicines’ TEVIMBRA in First-Line HER2+ GEA TEVIMBRA plus ZIIHERA and chemotherapy regimen delivered statistically significant median OS of 26.4 months, an unprecedented result in this challenging disease Results from the global Phase 3 HERIZON-GEA-01 study demonstrate potential to change clinical practice in advanced HER2+ gastroesophageal adenocarcinoma BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for TEVIMBRA ® (tislelizumab) in combination with ZIIHERA ® (zanidatamab) and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2-positive (HER2) gastric, gastroesophageal junction, or esophageal adenocarcinoma. The FDA has also granted Breakthrough Therapy Designation to the regimen of ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy, with and without TEVIMBRA, in this indication. Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said: “HERIZON‑GEA‑01 has the potential to shift the treatment paradigm in this historically difficult-to-treat disease, with the TEVIMBRA-conta

Company press release