FDA Approves Updated Labeling for Capecitabine Tablets

The FDA has approved updated labeling for capecitabine tablets (Xeloda) under an initiative aimed to ensure labeling information is clinically meaningful and scientifically up to date.

The initiative, Project Renewel, has been launched by the regulatory agency's Oncology Center of Excellence. With this collaborative program, external oncology experts and early-career scientists review existing published literature and get experience in the process for selecting, curating, and examining evidence for independent regulatory review.

Capecitabine is now approved for the following new and revised indications:

• adjuvant treatment for patients with stage III colon cancer as a monotherapy or as part of a combination chemotherapy regimen;
• perioperative treatment of adults with locally advanced rectal cancer as a part of a chemoradiation approach;
• treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a part of a combination chemotherapy regimen;
• treatment of patients with advanced or metastatic breast cancer as a monotherapy if an anthracycline- or taxane-containing chemotherapy is not indicated;
• treatment of patients with advanced or metastatic breast cancer in combination with docetaxel following progressive disease on a previous anthracycline-containing chemotherapy;
• treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction (GEJ) cancer as part of a combination chemotherapy regimen;
• treatment of adults with HER2-overexpressing metastatic gastric or GEJ adenocarcinoma who have not previously received treatment for metastatic disease as a part of a combination;
• adjuvant treatment of adults with pancreatic adenocarcinoma as part of a combination chemotherapy regimen.

Other labeling revisions for capecitabine were also made. There is now an option for a lower starting dose of patients with metastatic breast cancer, severe renal impairment has been omitted as a contraindication, and information on risks from exposure to crushed tablets has been added under the Warnings and Precautions section.

Additionally, additional information has been shared regarding the use of capecitabine and dihydropyrimidine dehydrogenase deficiency. Information pertaining to clinical pharmacology of the drug has been updated and revised, and updates and revisions have also been made to the Patient Counseling Information section as well as the Patient Information document.

Reference

1. FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal. News release. FDA. December 14, 2022. Accessed December 14, 2022. https://bit.ly/3BAgjw4