The FDA has updated the labeling for fludarabine phosphate injection under Project Renewal, an initiative by the Oncology Center of Excellence (OCE) to modernize the labeling of older oncology drugs. This marks the third drug to receive a labeling update under the program.
With this approval, fludarabine phosphate injection is indicated for adult patients with B-cell chronic lymphocytic leukemia (CLL) as part of a combination regimen, and for those with B-cell CLL who have not responded to or whose disease has progressed during treatment with at least one alkylating-agent containing regimen.
Key Revisions in Updated Labeling
The updated labeling for fludarabine phosphate injection includes key revisions to enhance clinical clarity and utility. Notably, the dosage regimen has been revised to specify the recommended dosage when used in combination with cyclophosphamide and rituximab, 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. 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.
Building on its success in oncology, Project Renewal is now expanding its efforts to update the labeling of older drugs in other therapeutic areas.
