FDA Approves New Dosing Regimens, Indications for Capecitabine Across Multiple Cancer Types

The FDA’s approval of new indications and dosing regimens of capecitabine across several cancer types, including breast cancer and colon cancer, marks the first drug to receive an update under the agency’s Project Renewal program.

The FDA has approved updated labeling for capecitabine (Xeloda) tablets under its Project Renewal program, according to a press release from the agency.

Project Renewal is an initiative to keep older and commonly prescribed cancer drugs’ labeling up to date. The program brings cancer experts and early-career scientists to review existing literature to evaluate evidence of the drugs’ current use.

Of note, capecitabine was first approved by the FDA in 2001 as a first-line therapeutic to treat patients with metastatic colorectal cancer.

Over the past 20 years, capecitabine has been approved across several cancer types including in combination with lapatinib for advanced breast canceras well as in combination with docetaxel for metastatic breast cancer.

The new and revised indications of capecitabine, according to the FDA release, include:

  • 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;
  • and adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.

Moreover, the updated approval has removed severe kidney function impairment as a contraindication for use of capecitabine. The updated approval also includes the option for a lower starting dose of capecitabine for patients with metastatic breast cancer.

The FDA noted that the recommended capecitabine dose depends on its indication.

This updated approval marks the first decision from the FDA under the Project Renewal program, according to the release.

Reference

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 15, 2022. https://bit.ly/3Ysotk8