Federal Register #FDA-2025-E-0845

FDA Notice: Regulatory Review Period for VYLOY (zolbetuximab-clzb) Patent Extension

This notice from the Food and Drug Administration (FDA) provides information on the regulatory review period determination for the biologic VYLOY (zolbetuximab-clzb): - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Astellas Pharma Inc. - TRON Translationale Onkologie an der Universitastsmedizin der Johannes Gutenberg-Univeristat Mainz Gemeinnutzige GmbH - Product Details: - VYLOY (zolbetuximab-clzb), a human biological product - Indicated for first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN 18.2 positive tumors - Notable Requirements: - Regulatory review period determination is part of the patent extension process - No procurement or award of products or services is involved; this is an informational notice - Applications for patent extension were submitted to the USPTO - FDA-approved test required for CLDN 18.2 positivity - Locations: - FDA offices in Rockville, MD - This notice is required by law and does not solicit bids or proposals.

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the human biological product VYLOY (zolbetuximab-clzb), which is indicated for the first-line treatment of adults with certain types of gastric or gastroesophageal junction adenocarcinoma. This notice is published as required by law following the submission of patent extension applications to the U.S. Patent and Trademark Office (USPTO). The regulatory review period includes a testing phase and an approval phase, with specific dates verified by the FDA. Interested parties may submit comments or petitions regarding the determination or the applicant's diligence during the review period.

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