On December 14, the U.S. Food and Drug Administration (FDA) approved updated labeling for capecitabine tablets (Xeloda) under Project Renewal, an Oncology Center of Excellence 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.
Capecitabine 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 adult patients 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 adult patients with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen
- 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
- Adjuvant treatment of adult patients 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 capecitabine and dihydropyrimidine dehydrogenase deficiency
- Clinical pharmacology information is updated and revised
- The Patient Counseling Information section and the Patient Information document are updated and revised.
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.
More on Project Renewal
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 health-care providers.
