FDA Updates Fludarabine Labeling Under Project Renewal Initiative

• The FDA has approved an updated drug labeling for fludarabine phosphate (fludarabine phosphate injection) under Project Renewal.
• Project Renewal is an Oncology Center of Excellence (OCE) initiative working to update labeling information for older oncology drugs, ensuring for information to be accurate, clinically meaningful, and up to date.
• This marks the third drug to receive a labeling update under Project Renewal.

The FDA has updated the labeling for fludarabine phosphate injection under Project Renewal, an initiative by the Oncology Center of Excellence to update labeling for older oncology drugs, marking the program's third update.¹

With this approval, fludarabine phosphate injection is available as a component of a combination regimen for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) and for the treatment of adults with B-cell CLL who have not responded to or whose disease has progressed during treatment with at least 1 alkylating-agent containing regimen.

The updated labeling for fludarabine phosphate injection also includes key revisions to enhance clinical clarity and utility. The dosage regimen has been revised to specify the recommended dosage when used in combination with cyclophosphamide and rituximab (Rituxan), providing clearer guidance for combination therapy.

Additionally, the boxed warning has been removed, with the relevant safety information now integrated into the Warnings and Precautions section to streamline risk communication.

About Project Renewal

Project Renewal is an FDA initiative led by the Oncology Center of Excellence to modernize the labeling of oncology drugs with decades of use and post-marketing experience. The collaborative program uses external oncology experts and early-career scientists to review published literature and gain experience in evaluating evidence for FDA review.

This initiative aims to be transparent about the FDA’s evaluation process and evidentiary standards while emphasizing the importance of drug labeling as a key information resource.

Project Renewal is aligned with the FDA’s mission to protect public health through assessing scientific data that is publicly available to update the necessary prescribing and patient information to keep agents safe and effective.² By creating a set of processes and procedures to help inform FDA decisions, Project Renewal is working to address this public health challenge. The initiative also aims to update indications for use, dosage and administration of certain drugs, as well as other clinically significant information.

Additionally, Project Renewal allows for the opportunity to engage with the oncology community and improve awareness of FDA drug labeling as an information resource.

Building on its success in oncology, Project Renewal is now expanding its efforts to update the labeling of older drugs in other therapeutic areas.

REFERENCES

1. FDA approves updated drug labeling for fludarabine phosphate under Project Renewal. News release. FDA. November 19, 2024. Accessed November 20, 2024. https://tinyurl.com/yck7u9dp
2. Project Renewal. FDA. Updated August 8, 2024. Accessed November 20, 2024. https://tinyurl.com/4uytpnub