Federal Register #FDA-2025-E-0372

FDA Regulatory Review Period Determination for ZIIHERA (zanidatamab-hrii) Patent Extension

This notice from the Food and Drug Administration (FDA) details the regulatory review period determination for ZIIHERA (zanidatamab-hrii), a biologic for cancer treatment, in the context of a patent extension application. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - U.S. Patent and Trademark Office (USPTO) involved for patent extension - OEMs and Vendors: - Zymeworks BC Inc. (applicant and manufacturer of ZIIHERA) - Product Requested: - ZIIHERA (zanidatamab-hrii), a human biological product - Indication: Treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer - No part number or quantity specified (regulatory notice, not a procurement) - Unique/Notable Requirements: - Notice pertains to regulatory review period for patent extension, not a procurement or contract award - Review period totals 3,038 days; applicant seeks 1,346 days of patent term extension - FDA-approved test required for HER2-positive status determination - No procurement, contract, or purchase is being solicited; this is a regulatory action related to intellectual property rights.

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the human biological product ZIIHERA (zanidatamab-hrii), which is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer. This determination is published as required by law following an application to the U.S. Patent and Trademark Office (USPTO) for patent extension. The regulatory review period includes a testing phase starting July 29, 2016, and an approval phase ending November 20, 2024, totaling 3,038 days. The applicant seeks 1,346 days of patent term extension.

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