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

December 16, 2022

On December 14, 2022, the U.S. Food and Drug Administration approved (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-updated-drug-labeling-including-new-indications-and-dosing-regimens-capecitabine) 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:

Additional labeling revisions included:

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 (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020896s044s051lbl.pdf).

Project Renewal (https://www.fda.gov/about-fda/oncology-center-excellence/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 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 800-FDA-1088.

For assistance with single-patient investigational new drug applications, contact OCE’s Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate) at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov (mailto:OncProjectFacilitate@fda.hhs.gov).


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