The FDA Approves Labeling Update for Sandoz in the Treatment of B-Cell CLL

The Food and Drug Administration (FDA) has approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection; Sandoz) in the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) under the Oncology Center of Excellence’s initiative, Project Renewal, according to a news release from the FDA.

The Project Renewal initiative is aimed at updating labeling information of older drugs for the treatment of cancer in order to ensure that information is clinically meaningful and scientifically up to date. Notably, this is the third drug to receive a labeling update under Project Renewal.

Furthermore, Project Renewal serves as a way to collaboratively leverage external oncology experts and early-career scientists in the review of existing literature that is published. This is done to gain first-hand experience in the evaluation of evidence for independent FDA review. The collaborative initiative is intended to provide transparency on FDA’s evaluation process and evidentiary standards, while keeping older, commonly prescribed oncology drugs’ labeling up to date. Additionally, Project Renewal is meant to improve the awareness of drug labeling as an information resource.

Furthermore, the news release noted that the initiative, while aiming to update oncology drug labels, still has limitations. The release notes that, “Project Renewal is limited to updating the label of older oncology drugs with decades of use and substantial post-marketing experience.”

At present, the injection of Sandoz is currently approved for two indications. In the first, Sandoz serves as a component of a combination regimen for the treatment of adults with B-cell CLL. In the second, the injection is utilized for the treatment of adults with B-cell CLL who have not responded to their current treatment, or whose disease has progressed while on a particular treatment, which contains at least one alkylating-agent containing regimen.

When looking to how these indications have changed, a boxed warning was removed from treatment with the Sandoz injection and is now instead incorporated into the Warnings and Precautions section of the label. The new and revised label indications also updated the dosing regimen of the agent; this was revised in order to include the recommended dosage for use in combination with cyclophosphamide and Rituxan (rituximab).

Previous dosing recommendations from the FDA cited a recommended dose of 25 milligrams per square meter in adults with B-cell CLL when administered intravenously over a period of approximately 30 minutes daily for five consecutive days; it was also noted that each five-day course of treatment should commence every 28 days. Additionally, the label stated to reduce the dose in patients with creatinine clearance between 30 and 70 milliliters per minute per square meter of body surface area.

The previous indication went on to note that there are some patients in which the agent is not recommended due to increased toxicity, including patients with advanced age, renal impairment and bone marrow impairment. These patients should be monitored closely for excessive toxicity and the dose should be modified accordingly.

Although the optimal duration of treatment has not been clearly established, it is recommended that three additional cycles of the injection are given following the achievement of a maximal response followed by the discontinuation of the drug.

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