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FDA grants priority review to BeOne’s TEVIMBRA combo in first-line HER2+ GEA

PUBT·04/29/2026 10:02:55
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FDA grants priority review to BeOne’s TEVIMBRA combo in first-line HER2+ GEA
  • FDA granted Priority Review for BeOne sBLA for TEVIMBRA with ZIIHERA and chemotherapy for first-line unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma.
  • Agency also issued Breakthrough Therapy Designation for ZIIHERA with fluoropyrimidine- and platinum-based chemotherapy, with or without TEVIMBRA, in same setting.
  • Phase 3 HERIZON-GEA-01 interim data showed median overall survival of 26.4 months for TEVIMBRA regimen versus 19.2 months for trastuzumab control.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BeOne Medicines AG published the original content used to generate this news brief via Business Wire (Ref. ID: 202604290600BIZWIRE_USPR_____20260429_BW582815) on April 29, 2026, and is solely responsible for the information contained therein.