Regulatory approval

Published by the Food and Drug Administration. Approved

VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.

This is written in the approval document.

Citation

Astellas Pharma US, Inc. Vyloy (zolbetuximab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761365s000lbl.pdf. Revised October 2024. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	CLDN18.2 >= 75%, HER2-negative	Adenocarcinoma of the Gastroesophageal Junction	Fluorouracil, Oxaliplatin, Zolbetuximab
FDA (2)	CLDN18.2 >= 75%, HER2-negative	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine, Oxaliplatin, Zolbetuximab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-10-18	Food and Drug Administration	Indication received traditional approval.