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On November 20, 2024, the Food and Drug Administration granted accelerated approval to zanidatamab-hrii, a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic Biliary tract cancer / Cholangiocarcinoma (HER2 m), as detected by an FDA-approved test.
Zanidatamab demonstrated meaningful clinical benefit with a manageable safety profile in patients with treatment-refractory, HER2-positive biliary tract cancer. These results support the potential of zanidatamab as a future treatment option in HER2-positive biliary tract cancer
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