FDA places hold on Threshold trial
These abnormalities include three serious adverse events observed at three months of dosing in the phase III European/Canadian clinical trial and three additional observations of elevated liver enzymes
The US Food and Drug Administration (FDA) has approved two Jazz Pharmaceuticals regimens containing Ziihera (zanidatamab-hrii) for the first-line treatment of adults with unresectable, locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastroesophageal adenocarcinoma (GEA).