The zanidatamab-plus-chemotherapy arm met its overall survival end point at the second interim analysis of the phase 3 HERIZON-GEA-01 trial.
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The conditional approval of fanregratinib is supported by pivotal phase 2 data showing a 42.5% objective response rate in pretreated FGFR2-altered intrahepatic cholangiocarcinoma.
The FDA approval of daraxonrasib was based on data from the phase 3 RASolute 302 trial in previously treated metastatic pancreatic ductal adenocarcinoma.
Ivonescimab plus chemotherapy significantly improved overall survival vs durvalumab plus chemotherapy in advanced biliary tract cancer.
The FDA has approved zanidatamab plus chemotherapy with/without tislelizumab in frontline HER2-positive GEA based on data from HERIZON-GEA-01.
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