Updated Capecitabine Approval Ignites ‘Broad Impact’ in Cancer Under New FDA Program


Under a new FDA initiative, the agency recently updated a decades’ old approval of the chemotherapy capecitabine. This move, according to an expert, will springboard further change in the treatment of cancer.

A recent updated approval of the chemotherapy capecitabine (Xeloda) begins an initiative that will lead to a “broad impact” within the cancer space, according to an expert.

Last month, the FDA approved updated indications of capecitabine tablets under its recently established Project Renewal Program.1 Capecitabine was first approved in 2001 as a first-line treatment option for patients with colorectal cancer.

According to an expert from the University of Cincinnati School of Pharmacy, the Project Renewal Program is an FDA initiative to review agents like capecitabine to see if updated labelling could be beneficial for patients.

According to an expert from the University of Cincinnati School of Pharmacy, the Project Renewal Program is an FDA initiative to review agents like capecitabine to see if updated labelling could be beneficial for patients.

Over the past 2 decades, the FDA has approved additional indications for capecitabine either alone or in combination with other treatments.

Now, the updated labeling includes additional patients with various cancer types, but most prominently affects those with colorectal or breast cancer.

Rowena N. Schwartz, PharmD, BCOP, an associate professor of pharmacy practice at University of Cincinnati School of Pharmacy, spoke with CancerNetwork® to discuss these updates, and how they will affect clinical practice. Moreover, she reviewed how Project Renewal is an exciting new initiative, and where she expects to see updated cancer drug labels in the future.

What is the Project Renewal Program?

The Project Renewal program is a new initiative established by the FDA to take products, like capecitabine, that have been on the market for years and review them to see if updated labeling could be beneficial for patients.2 For the labeling information to be updated, the FDA Oncology Center of Excellence reviews relevant scientific evidence from existing literature in each respective field.

Schwartz indicated that this is an interesting project as it can further help define which cancer treatments are best for each patient population.

Along with this new program, the FDA wanted to create a repeatable process to help update the labeling information of existing cancer treatments as well as include potential new indications for use. This new initiative, according to Schwartz, will further help clinicians make critical decisions for patient care.

Schwartz advised clinicians to reference package inserts if they have questions as to whether a certain drug is pertinent to patient care.

“When I see this [initiative], I think of it as a way of taking these very important drugs that have been out for a while and making sure those package inserts contain that same type of robust information. If I’m in practice, and I need to look up something fast, I can do it and I can get a place I look for other drugs as well,” Schwartz said.

Update to Capecitabine Labeling

The FDA’s updated approval of the capecitabine label means that patients with these following types of cancer may receive the chemotherapy as part of their treatment:

  • 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.

Schwartz noted that capecitabine has always been a standard of care for the current cancer types it’s approved for, however, she explained that clinicians can view the current National Comprehensive Cancer Network (NCCN) guidelines or the American Society of Clinical Oncology (ASCO) guidelines to determine a course of appropriate treatment if they have questions regarding their patient’s fit for treatment.

In addition to this updated labeling, there were a few revisions to the existing indications.

The FDA revised the dosing and updated it for several regimens with an option to now lower the starting dose for patients who have metastatic breast cancer. Renal function impairment has been removed as a contraindication, and there has been an addition to the risk from exposure to the crushed tablet under Warnings and Precautions.

Of note, under the Project Renewal program’s approval, the recommended capecitabine dose depends on the indication.

Schwartz noted how this updated approval and potential future updates may affect health care providers in their practice. She explained how when treatments are approved, it helps with insurance reimbursement.

“There are other ways that you can get drugs approved for use if they’re on [NCCN] Compendium guidelines, but having it in the package insert certainly is a really strong case for that drug to be used,” She said in the interview.

Schwartz emphasized that while there are other treatment options available, relying on that package insert can be crucial and a reliable source when looking for specific information.

Use of Capecitabine in Practice

Capecitabine is made up of both normal and tumor cells that metabolize 5-fluorouracil.3 Through 2 different mechanisms, it helps to bind to thymidylate synthase which inhibits the thymidylate from uracil.

When asked to describe the use of capecitabine in practice, Schwartz said, “The place where [capecitabine] initially came out in practice, is in those diseases, where we used 5-FU or 5-fluorouracil [including] colon cancer, breast cancer, but it’s used in a number of different types of cancers. Over time, as studies have come out, its place in therapy has been established in other disease states, some of them common and so those are the things that you're going to see in these revised indications.”

The Mayo Clinic outlined the average dose of capecitabine tablets to take each day, specifically for patients who have breast or colon cancer.4 In adults who are receiving the medicine alone, the dose should be based on body weight with the first 2500 mg/m2 being determined by body size per day divided into 2 doses and taken 12 hours apart. Treatment should be taken for 2 weeks on, 1 week off, and given in 3 cycles. The dose regimen is the same if capecitabine is combined with docetaxel.

Treatment should be taken with food or within 30 minutes of eating. Of note, if a dose is skipped, the doubling of doses is not advised.

Looking Toward the Future

This updated information must be easily accessible to providers as it is important for their daily practice, according to Schwartz.

“I like when information is available to all providers,” she said. “When I say providers, I mean the entire healthcare team. If you’re a pharmacist in the community, you can go to a place that you’re used to already accessing and learn about how the dose modifications may be important in this drug, or look at drug interactions, and potential AEs, those are things that are helpful to have available.”

From a multidisciplinary approach, the package insert is something available to everyone and can lend to acquired information if there are ever questions regarding dosing regimens.

Schwartz said she believes that as this new initiative from the FDA takes off, more labels of different drugs across various cancer types will be updated.

“The focus of this project is to look at other drugs that have been available for a while, where the package inserts don’t reflect the current practice,” she concluded. “There is potential with this project to do that and there will be a broad impact.”


  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 January 18, 2023. https://bit.ly/3Ysotk8
  2. U.S. Food and Drug Administration. Project Renewal. Accessed January 18, 2023. https://bit.ly/3IWjbYy
  3. U.S. Food and Drug Administration. Xeloda (capecitabine) tablets. Accessed January 18, 2023. https://bit.ly/3Wk9jLo
  4. The Mayo Clinic. Capecitabine (oral route). Accessed January 18, 2023. https://mayocl.in/3CYMBlc
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