Federal Register #FDA2025E0485

FDA Regulatory Review Period Determination for BIZENGRI Patent Extension

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, addresses the regulatory review period for BIZENGRI, a human biological product: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEM and Vendor: - Merus N.V. (OEM and applicant for patent extension) - Product Requested: - BIZENGRI (zenocutuzumab-zbco) - Approved for treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma with neuregulin 1 (NRG1) gene fusion - Regulatory Review Period: - Total: 2,909 days - Testing phase: 2,634 days - Approval phase: 275 days - Unique Requirements: - Determination relates to patent extension application - Public comments and petitions invited regarding the review period and applicant's due diligence - No procurement or contract for goods/services is being solicited; this is a regulatory notice regarding patent extension.

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for BIZENGRI, a human biological product, following an application submitted to the U.S. Patent and Trademark Office (USPTO) for patent extension. BIZENGRI is approved for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma harboring a neuregulin 1 gene fusion. The regulatory review period includes a testing phase of 2,634 days and an approval phase of 275 days, totaling 2,909 days. The FDA invites comments and petitions regarding the determination and due diligence of the applicant during the regulatory review period.

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