FDA approves updated drug labeling for fludarabine phosphate under Project Renewal

On November 19, 2024, the Food and Drug Administration approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. This is the third drug to receive a labeling update under Project Renewal.

Full prescribing information for fludarabine phosphate injection will be posted on Drugs@FDA.

Project Renewal is a collaborative program that leverages external oncology experts and early-career scientists to review existing published literature and gain first-hand experience in the evaluation of evidence for independent FDA review. Project Renewal is intended to keep older, commonly prescribed oncology drugs’ labeling up to date, while providing transparency on FDA’s evaluation process and evidentiary standards and improving awareness of drug labeling as an information resource.

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.

Project Renewal is limited to updating labeling of older oncology drugs with decades of use and substantial post-marketing experience. For information on the key studies supporting a new or revised indication, see the prescribing information for Fludarabine Phosphate Injection.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X: @FDAOncology.