BeOne wins FDA approval for Tevimbra-based combo in first-line HER2+ stomach & oesophageal cancer
BeOne Medicines (formerly BeiGene) has won US Food and Drug Administration approval for a new first-line treatment for advanced HER2-positive cancers of the stomach, oesophagus and the junction between them (collectively called gastroesophageal adenocarcinoma, or GEA). Announced on 25 August 2026, the approval clears BeOne's immunotherapy Tevimbra (tislelizumab) used together with Ziihera (zanidatamab) — a HER2-targeting antibody — plus chemotherapy.
Why it matters: this is a hard-to-treat cancer where, in the US, fewer than 40% of patients live beyond two years, and roughly one in five GEA patients has the HER2-positive form. The new regimen is the first immunotherapy-based combination to push median overall survival past two years in this setting.
In the Phase 3 HERIZON-GEA-01 trial (published earlier this year in the New England Journal of Medicine), patients on the Tevimbra combination lived a median of 26.4 months, versus 19.2 months for the control group, and went 12.4 months before their disease worsened, versus 8.1 months. Crucially, the benefit held regardless of PD-L1 status — a biomarker that often dictates who responds to immunotherapy — meaning doctors can use it more broadly.
Tevimbra is BeOne's first approved solid-tumour asset; Ziihera (zanidatamab) originated with Zymeworks and is partnered with Jazz Pharmaceuticals.
