NasdaqGS:JAZZPharmaceuticals
Will Ziihera’s Priority Review in First-Line HER2-Positive Gastric Cancer Shift Jazz Pharmaceuticals’ (JAZZ) Narrative?
Jazz Pharmaceuticals recently announced that the FDA previously accepted, with Priority Review, its supplemental Biologics License Application for Ziihera (zanidatamab-hrii) combinations in first-line treatment of adult patients with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or gastroesophageal adenocarcinoma, with an August 25, 2026 PDUFA target action date.
This filing, backed by Phase 3 HERIZON-GEA-01 data and supported by Breakthrough...