Zanidatamab: First Approval
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Abstract:
Zanidatamab (ZIIHERA®; zanidatamab- hrii), a bi-specific antibody targeting two non-overlapping epitopes of the human epidermal growth factor receptor 2 (HER2) protein, is being developed by Jazz Pharmaceuticals and BeiGene Ltd under license agreements from Zymeworks Inc., the developer of the molecule, for the treatment of HER2-expressing solid tumours. This article summarizes the milestones in the development of zanidatamab leading to this first accelerated approval for use in adults with previously treated, unresectable or metastatic HER2+ (IHC3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
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