FDA expands gastroesophageal cancer options
Phase 3 findings showed longer median progression-free survival with zanidatamab-containing regimens vs trastuzumab plus chemotherapy.
By
Kathryn Wighton
August 25, 2026
Clinical Scorecard: FDA expands gastroesophageal cancer options
At a Glance
Category Detail
Condition HER2-positive gastroesophageal adenocarcinoma Key Mechanisms Zanidatamab-hrii is a bispecific antibody targeting HER2. Target Population Adults with unresectable locally advanced or metastatic HER2-positive tumors. Care Setting Oncology
Key Highlights
Two first-line treatment options approved containing zanidatamab-hrii. Zanidatamab-hrii plus tislelizumab-jsgr and chemotherapy reduces disease progression risk by 35%. Median progression-free survival is 12.4 months with zanidatamab vs 8.1 months with trastuzumab. Zanidatamab-hrii regimens reduce risk of death by 28% compared to trastuzumab. Median overall survival is 26.4 months with zanidatamab-hrii plus tislelizumab-jsgr vs 19.2 months with trastuzumab. Diarrhea is the most common adverse reaction reported. Guideline-Based Recommendations
Diagnosis
HER2-positive tumors must be immunohistochemistry 3-positive or 2-positive and in situ hybridization-positive. Management
Zanidatamab-hrii can be used with tislelizumab-jsgr and chemotherapy or with chemotherapy alone. Monitoring & Follow-up
Monitor for diarrhea and other serious adverse reactions. Risks
Boxed warnings for diarrhea and embryo-fetal toxicity. Patient & Prescribing Data
Patients with HER2-positive gastroesophageal adenocarcinoma.
Serious adverse reactions occurred in 59% of patients with the combination regimen.
Clinical Best Practices
Consider patient HER2 status when selecting treatment. Monitor patients closely for adverse reactions, particularly diarrhea. Related Resources & Content
