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Jazz wins FDA approval for Ziihera GEA treatment
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Jazz wins FDA approval for Ziihera GEA treatment

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  • Jazz Pharmaceuticals (NASDAQ:JAZZ) received U.S. FDA approval for two Ziihera regimens in HER2-positive gastroesophageal adenocarcinoma.
  • Phase 3 HERIZON-GEA-01 data showed improvements in progression-free and overall survival compared with trastuzumab plus chemotherapy.
  • The approved regimens include Ziihera combinations with Tevimbra plus chemotherapy or chemotherapy alone.

Jazz Pharmaceuticals (NASDAQ:JAZZ) received U.S. Food and Drug Administration approval for two Ziihera (zanidatamab-hrii) treatment regimens for adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma.

The approved regimens include Ziihera combined with Tevimbra (tislelizumab) plus fluoropyrimidine- and platinum-containing chemotherapy for HER2-positive IHC 3+ and IHC 2+/ISH+ tumors, and Ziihera with chemotherapy alone for HER2-positive IHC 3+ tumors.

In the Phase 3 HERIZON-GEA-01 trial, Ziihera-based regimens showed median progression-free survival of 12.4 months compared with 8.1 months for trastuzumab plus chemotherapy, while median overall survival was 26.4 months compared with 19.2 months.

The trial results showed a 35% reduction in the risk of disease progression or death and a 28% reduction in the risk of death compared with trastuzumab plus chemotherapy, while the approved regimens include boxed warnings for severe diarrhea and embryo-fetal toxicity.

Jazz Pharmaceuticals stated that additional risks associated with Ziihera include left ventricular dysfunction and infusion-related reactions.

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