The Food and Drug Administration (FDA) has approved updated labeling for Xeloda (capecitabine tablets) under Project Renewal, a public health initiative established by the FDA’s Oncology Center of Excellence.

Utilizing a network of external oncology experts and early career scientists, the collaborative program is intended to keep the labeling for commonly prescribed older oncology medications updated through a review of existing published literature.

The labeling for Xeloda, which is the first drug to receive label changes under this program, has now been updated to include the following new and revised indications:

  • Adjuvant treatment of Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen.
  • Perioperative treatment of locally advanced rectal cancer as a component of chemoradiotherapy.
  • Treatment of unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen.
  • Treatment of advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated.
  • Treatment of advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy.
  • Treatment of unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen.
  • Treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease as a component of a combination regimen.
  • Adjuvant treatment of pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.

Additional revisions to the Xeloda prescribing information include:

  • Updates to several dosage regimens, including an option for a lower starting dose for patients with metastatic breast cancer.
  • The removal of severe renal impairment as a contraindication.
    • If an alternative treatment is unavailable, Xeloda could be administered to such patients on an individual basis with a reduced starting dose, close monitoring, and dose modifications guided by observed adverse reactions.
  • Information on risks from exposure to crushed tablets.
    • If tablets are to be cut or crushed, this should be done by a professional trained in the safe handling of cytotoxic drugs.
  • More information on the use of Xeloda in patients with dihydropyrimidine dehydrogenase deficiency.

Studies supporting the revisions are available in the updated prescribing information.

Reference

FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal. News release. US Food and Drug Administration. Accessed December 15, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-updated-drug-labeling-including-new-indications-and-dosing-regimens-capecitabine.