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'Practice-Changing' Data Expand Zanidatamab's Approval to Gastroesophageal Cancer
The approval was based on Phase 3 data showing a 35% lower risk of progression or death and a 28% lower risk of death, the company said.
- On Tuesday, August 25, 2026, the FDA approved Ziihera regimens for first-line treatment of HER2-positive gastroesophageal adenocarcinoma, Jazz Pharmaceuticals announced. The approval covers advanced disease regardless of PD-L1 status.
- Results from the Phase 3 HERIZON-GEA-01 trial showed Ziihera-containing regimens significantly improved outcomes. Patients achieved median overall survival of 26.4 months, the longest reported in a Phase 3 trial for this setting.
- Ziihera-Based treatments reduced the risk of disease progression or death by 35% and lowered the risk of death by 28% compared to Herceptin plus chemotherapy. Benefits remained consistent across prespecified subgroups including PD-L1 status.
- Approximately 12,000 U.S. patients may now be eligible for treatment, RBC Capital Markets analyst Leonid Timashev noted. Timashev wrote the clearance creates a market opportunity north of $1.5 billion, with expectations for relatively quick uptake.
- Jazz Pharmaceuticals continues developing Ziihera for other HER2-expressing cancers, including potential settings for breast tumors. The company acquired most rights through a 2022 deal with Zymeworks, positioning it to expand the drug's clinical footprint.
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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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Jazz Pharmaceuticals Launches Ziihera After FDA Nod in HER2-Positive GEA
Jazz Pharmaceuticals (NASDAQ:JAZZ) outlined its plans for the U.S. launch of Ziihera following FDA approval of the therapy for first-line HER2-positive unresectable, locally advanced or metastatic gastroesophageal adenocarcinoma, or GEA. Ziihera, or zanidatamab, is approved in combination with tisl
·Sioux Falls, United States
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Coverage Details
Total News Sources17
Leaning Left6Leaning Right2Center6Last UpdatedBias Distribution43% Left, 43% Center
Bias Distribution
- 43% of the sources lean Left, 43% of the sources are Center
43% Center
L 43%
C 43%
14%
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