Industry News Archive

FDA Updates Capecitabine Indications and Dosing Regimens

On December 14, 2022, the U.S Food and Drug Administration (FDA) approved updated labeling for capecitabine under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for older, commonly prescribed oncology drugs.

Capecitabine 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 capecitabine and dihydropyrimidine dehydrogenase (DPD) deficiency
  • Clinical pharmacology information is updated and revised
  • The patient counseling information section and patient information document are updated and revised.

For more information, read the FDA announcement.

Posted 12/16/2022


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