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'Practice-Changing' Data Expand Zanidatamab's Approval to Gastroesophageal Cancer
The approval is based on Phase 3 data showing Ziihera regimens improved progression-free and overall survival versus trastuzumab plus chemotherapy, with median OS reaching 26.4 months.
- On Tuesday, the FDA approved Jazz Pharmaceuticals' Ziihera for first-line treatment of HER2-positive gastroesophageal adenocarcinoma, available in combination with chemotherapy alone or with Tevimbra immunotherapy.
- Approximately 20% of patients with GEA, the fifth most common cancer globally, have HER2-positive disease and face high mortality rates, creating urgent need for new treatment options.
- The Phase 3 HERIZON-GEA-01 trial showed Ziihera-containing regimens reduced disease progression or death risk by 35%, achieving median overall survival of 26.4 months versus 19.2 months with trastuzumab plus chemotherapy.
- According to RBC Capital Markets analyst Leonid Timashev, the clearance opens a market opportunity exceeding $1.5 billion; Jazz earned $250 million upfront with $1.3 billion in potential milestones.
- Dr. Geoffrey Ku, associate attending physician at Memorial Sloan Kettering Cancer Center, noted the regimen benefits patients regardless of PD-L1 status, emphasizing HER2 testing at diagnosis remains critical for treatment selection.
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Jazz Pharmaceuticals plc (JAZZ) Discusses FDA Approval and Commercial Launch of ZIIHERA for First-Line HER2-Positive GEA Transcript
Jazz Pharmaceuticals plc (JAZZ) Discusses FDA Approval and Commercial Launch of ZIIHERA for First-Line HER2-Positive GEA August 25, 2026 4:30 PM EDTCompany...
·Ra'anana, Israel
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stocktitan.netBeOne Medicines Announces U.S. FDA Approval for TEVIMBRA-Based Regimen for First-Line HER2+ GEA
TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status Regimen poised to become standard of care in this difficult-to-treat disease. SAN CARLOS, Calif. — BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global […]
·Toronto, Canada
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Total News Sources9
Leaning Left2Leaning Right2Center3Last UpdatedBias Distribution43% Center
Bias Distribution
- 43% of the sources are Center
43% Center
L 29%
C 43%
R 28%
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