FDA Grants Accelerated Approval to Zanidatamab-hrii for Select Cases of Biliary Tract Cancer

FDA Grants Accelerated Approval to Zanidatamab-hrii for Select Cases of Biliary Tract Cancer

Posted on 11/22/2024

On November 20, the US Food and Drug Administration (FDA) granted accelerated approval to zanidatamab-hrii, a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive IHC 3+ biliary tract cancer, as detected by an FDA-approved test.

For more information read the FDA announcement and the Jazz Pharmaceuticals press release.

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