Capecitabine's Label Updated Under FDA Project Renewal Initiative

M. Alexander Otto, PA, MMS

December 15, 2022

Today, the US Food and Drug Administration approved several indications and other updates to the label of capecitabine tablets (Xeloda) under the agency's Project Renewal initiative.

The goal of this pilot program, established by the agency's Oncology Center of Excellence, is to update labeling information for older oncology drugs to ensure the indications are clinically meaningful and scientifically up to date, based on expert opinion and the latest literature. Capecitabine is the first drug to receive a labeling update under the program, according to an FDA press release announcing the changes.

"Many oncology products on the market today have outdated labeling, despite new information coming available in the post-marketing setting that could support labeling changes, including updated indications for use. Project Renewal is working to address this public health challenge," the agency said.

"Labeling updates made under Project Renewal could reduce potential risk to patients by providing healthcare providers with updated evidence to inform safe and effective use of oncology products," the agency added.

Capecitabine had previously received approvals for several indications in metastatic colorectal and breast cancer as well as for Dukes' C colon cancer.

Capecitabine's new and revised indications now 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.

  • Adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.

Capecitabine's dosing regimen has also been updated to include a lower starting dose for patients with metastatic breast cancer.

Other updates include removal of severe renal impairment as a contraindication, new warning information about exposure to crushed tablets, as well as additional information on the risks of using capecitabine in patients with dihydropyrimidine dehydrogenase (DPD) deficiency.

The patient counseling information section and the patient information document have been updated to reflect these changes.

The FDA noted that Project Renewal is limited to updating labeling of older oncology drugs with decades of use, multiple supportive clinical studies, and substantial post-marketing experience. 

M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email:

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