Jazz Pharma gets FDA approval for Ziihera-based regimens in first-line HER2+ gastroesophageal adenocarcinoma

Jazz Pharmaceuticals plc

FDA approved Ziihera (zanidatamab-hrii) plus Tevimbra (tislelizumab-jsgr) and chemo for all HER2+ GEA (IHC 3+ and IHC 2+/ISH+) regardless of PD-L1 status.
Second approval: Ziihera plus chemo for HER2+ IHC 3+ GEA; based on Phase 3 HERIZON-GEA-01 trial.
Trial showed 35% PFS risk reduction (12.4 vs 8.1 months) and 28% OS risk reduction (26.4 vs 19.2 months) vs trastuzumab plus chemo.
Jazz hosts investor webcast Aug 25, 4:30pm ET; Ziihera is first bispecific HER2-targeted antibody plus PD-1 inhibitor approved in this setting.

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