Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Capecitabine in patients with Adenocarcinoma of the Gastroesophageal Junction.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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.