FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal

  • Amanda Bridges
  • December 15, 2022

On December 14, 2022, the Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda, Genentech, Inc.) 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. This is the first drug to receive a labeling update under this pilot program.

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.

Xeloda is now 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 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 include:

  • The dosage regimen is revised and updated for several indications, including the option for a lower starting dose for patients with metastatic breast cancer;
  • Severe renal impairment is removed as a Contraindication;
  • Information on risks from exposure to crushed tablets is added under Warnings and Precautions;
  • Additional information is provided on the use of Xeloda and dihydropyrimidine dehydrogenase (DPD) deficiency;
  • Clinical pharmacology information is updated and revised;
  • Patient Counseling Information section and the Patient Information document are updated and revised.

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

The recommended capecitabine dose depends on the indication. View full prescribing information for Xeloda.

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 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

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