Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to capecitabine for the treatment of adult patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen.

This is written in the approval document as:

XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen.

Citation

Genentech, Inc. Xeloda (capecitabine) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s045s046s047s048s049s050s051lbl.pdf. Revised December 2022. Accessed October 30, 2024.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-positive	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine