FDA Approval Summary: Capecitabine Labeling Update under Project Renewal

Area of Science:

• Oncology
• Pharmacology
• Regulatory Science

Background:

• Capecitabine is an oral chemotherapy agent used in various cancer treatments.
• Existing prescribing information requires regular updates to reflect current scientific knowledge and clinical practice.
• The United States Prescribing Information (USPI) for older oncology drugs may not always be up-to-date.

Purpose of the Study:

• To summarize the FDA's approach to revising the USPI for capecitabine.
• To detail the updates made to capecitabine's indications, dosage, and safety information.
• To contextualize these revisions within the FDA's Project Renewal initiative.

Main Methods:

• Review and approval of supplemental New Drug Applications (NDAs) for capecitabine.
• Evaluation of proposed revisions to existing indications and dosage regimens.
• Assessment of updated safety information, including risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency.

Main Results:

• The FDA approved revised USPI for capecitabine on December 14, 2022.
• Updates included revised and new indications, updated dosage regimens, and enhanced safety information.
• Specific attention was given to the risk of capecitabine in patients with DPD deficiency.

Conclusions:

• The revisions ensure capecitabine prescribing information is clinically meaningful and scientifically current.
• Project Renewal facilitates the modernization of prescribing information for older oncology drugs.
• The updated USPI supports safe and effective use of capecitabine in cancer therapy.