Posted by Michael Wonder on 28 Apr 2026
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental biologics license application for Ziihera (zanidatamab-hrii) combinations in first-line HER2 positive locally advanced or metastatic gastric cancer
27 April 2026 - Jazz Pharmaceuticals today announced that the US FDA accepted for filing with priority review the supplemental biologics license application for Ziihera (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2 positive unresectable locally advanced or metastatic gastric, gastro-oesophageal junction or gastro-oesophageal adenocarcinoma.
The FDA has set a PDUFA target action date of 25 August 2026.
