FDA D.I.S.C.O. Burst Edition: FDA approves updated drug labeling including new indications and dosing regimens for Xeloda (capecitabine) tablets under Project Renewal
Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.
On December 14, 2022, the FDA approved updated labeling for capecitabine tablets (brand name 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.
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 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.
Full prescribing information for these approvals can be found at Drugs@FDA .
Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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