Xeloda (capecitabine) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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