Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration (FDA) granted approval to zolbetuximab 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. The package insert states that that eligible patients should have CLDN18.2 positive tumors, defined as >= 75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining. The package insert further states that this indication is based on Spotlight (8951-CL-0301) and Glow (8951-CL-0302), both phase 3, double-blind, randomized, multicenter studies that enrolled 1072 patients where the choice of either mFOLFOX6 (oxaliplatin, folinic acid, and fluorouracil) or CAPOX (oxaliplatin and capecitabine).

This is written in the approval document as:

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.

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.