FDA Updates Drug Labeling for Fludarabine Phosphate Under Project Renewal

On November 19, 2024, the FDA approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection; Sandoz) under Project Renewal, a public health initiative under the Oncology Center of Excellence program, which is designed to update labeling information for certain older oncology drugs to ensure information is clinically meaningful. This is the third drug to receive a labeling update under Project Renewal.¹

According to an FDA statement, “fludarabine phosphate injection is now approved for the following new and revised indications:

• as a component of a combination regimen for the treatment of adults 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 one alkylating-agent containing regimen.

Additional labeling revisions include:

• the dosage regimen was revised and updated to include the recommended dosage for use in combination with cyclophosphamide and rituximab; and
• the boxed warning was removed and this information was incorporated in the Warnings and Precautions section.”

According to the FDA statement, Project Renewal is limited to updating labeling of older oncology drugs with decades of use and substantial postmarketing experience. For information on the key studies supporting a new or revised indication, see the prescribing information for fludarabine phosphate injection.

Reference

1. FDA approves updated drug labeling for fludarabine phosphate under Project Renewal. Press release. FDA. Published November 19, 2024. Accessed November 20, 2024. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-updated-drug-labeling-fludarabine-phosphate-under-project-renewal