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FDA Grants Priority Review To BeOne Medicines' Supplemental Biologics License Application For Tevimbra (Tislelizumab) In Combination With Ziihera (Zanidatamab) And Chemotherapy For Untreated Unresectable Locally Advanced/Metastatic HER2-positive Gastric, Gastroesophageal Junction, Or Esophageal Adenocarcinoma

Benzinga·04/29/2026 10:03:15
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  • 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