FDA Labeling Update for Capecitabine Under Project Renewal Aptitude Health

FDA Labeling Update for Capecitabine Under Project Renewal

Oncology drugs are being developed at an increasingly rapid pace, but many of the newest agents are not replacing standards of care that have been in use for several years. Some of these older products have outdated labels that either do not include the most recent information, are in a suboptimal label format (not following Physician Labeling Rule format), or are commonly being used off-label in the US on the basis of recent research. To address these concerns, the United States Food and Drug Administration (FDA) Oncology Center of Excellence initiated a pilot project titled Project Renewal. In this public health initiative, the FDA is collaborating with external stakeholders to evaluate relevant scientific evidence from published literature and review product labels from older oncology drugs to ensure they are up-to-date with current knowledge. The first product to receive a new label under this program is capecitabine (Xeloda®; Genentech, Inc), which acquired several new and updated indications in December 2022 including colon, rectal, breast, gastrointestinal tract, and pancreatic cancers. The label revisions also include a dosing regimen change with a lower starting dose for patients with breast cancer, a new boxed warning about the risk of bleeding with concomitant use of vitamin K antagonists, and others.

High level
As the Project Renewal program continues, payor organizations and health systems may need to review formularies and protocols to ensure they align with the updated labels for products like capecitabine. Keeping current with these updates will help support the providers within their organizations by making it easy for them to access the latest information.

Ground level
The goal of Project Renewal is to inform the provider community of the latest information pertaining to commonly used cancer treatments. Clinicians may find that some treatments they are used to prescribing, such as capecitabine, receive changes to their labels as this program continues. Reviewing and following the revised labels may help reduce potential risks to some patients.