FDA approves updated drug labeling for fludarabine phosphate under Project Renewal
Regulatory approval: On Nov 19, 2024, the FDA approved updated labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under the Oncology Center of Excellence’s Project Renewal. The label now includes new and revised indications in adult B-cell chronic lymphocytic leukemia (CLL), updated dosing information for use with cyclophosphamide and rituximab, and removal of the boxed warning with related content moved to Warnings and Precautions. Full prescribing information will be posted on Drugs@FDA.
FDA labeling update (Project Renewal)
Type: Regulatory approval (labeling update)
Date: 2024-11-19
Agency: US FDA
On November 19, 2024, the FDA approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under Project Renewal, an Oncology Center of Excellence (OCE) initiative intended to update labeling for certain older oncology drugs based on review of existing published literature and post-marketing experience. FDA noted this is the third drug to receive a labeling update under Project Renewal.
New and revised indications (adults with B-cell CLL)
Fludarabine Phosphate Injection is now approved:
- As a component of a combination regimen for the treatment of adults with B-cell chronic lymphocytic leukemia (CLL); and
- For 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
- The dosage regimen was revised to include recommended dosing for use in combination with cyclophosphamide and rituximab.
- The boxed warning was removed and the information was incorporated into Warnings and Precautions.
FDA stated that key studies supporting new or revised indications are described in the prescribing information, which will be posted on Drugs@FDA.