On December 14, 2022, the U.S. Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda®) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. Capecitabine is the first drug to receive a labeling update under the pilot program.

FDA Approves Updated Drug Labeling Including New Indications and Dosing Regimens for Capecitabine Tablets Under Project Renewal

Capecitabine was approved for the following new and revised indications:

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

Additional labeling revisions included:

  • The dosage regimen was revised and updated for several indications, including the option for a lower starting dose for patients with metastatic breast cancer.
  • Severe renal impairment was removed as a contraindication.
  • Information on risks from exposure to crushed tablets was added under warnings and precautions.
  • Information was added about the use of capecitabine and dihydropyrimidine dehydrogenase deficiency.
  • Clinical pharmacology information was updated and revised.
  • The patient counseling information section and the patient information document were updated and revised.

Project Renewal is limited to updating labeling of older oncology drugs with decades of use, multiple supportive clinical studies, and substantial postmarketing experience. For information on the key studies supporting a new or revised indication, see capecitabine’s prescribing information.

The recommended capecitabine dose depends on the indication. 

View the full prescribing information for capecitabine.

Project Renewal is a collaborative program that leverages external oncology experts and early-career scientists to review existing published literature and gain first-hand experience in the selection, curation, and evaluation of evidence for independent FDA review. Project Renewal is intended to keep older, commonly prescribed oncology drugs’ labeling up to date while providing transparency on FDA’s deliberative evaluation process and evidentiary standards and improving awareness of drug labeling as an information resource for healthcare providers.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 800-FDA-1088.

For assistance with single-patient investigational new drug applications, contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.