Updated Leukemia Indications for Chemotherapy Drug
The FDA Project Renewal initiative has updated the approved indications for fludarabine phosphate chemotherapy in chronic lymphocytic leukemia.
The U.S. Food and Drug Administration (FDA) has approved updated labeling of fludarabine phosphate (Fludarabine Phosphate Injection), including 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)
- for adults with CLL that is refractory or that progressed during prior treatment with at least one alkylating agent-containing regimen
Additional updates were made regarding the recommended dosage for fludarabine phosphate when used in combination with cyclophosphamide and rituximab. The boxed warning information was removed and incorporated elsewhere.
The updates occurred under Project Renewal, an initiative of the Oncology Center of Excellence aimed at reviewing real-world data to update the approved indications for older drugs. While most FDA approvals happen while a drug retains patent protections, off-patent drugs that have existed for decades are no longer evaluated in the types of large clinical trials that garner new approvals. Project Renewal analyzes data from smaller studies investigating off-label uses for these drugs to update the approval indications. AACR has worked with the FDA Oncology Center of Excellence to advance Project Renewal, providing scientific advice and perspective.
Fludarabine phosphate is a chemotherapy drug that interferes with DNA synthesis and repair, thereby inhibiting the growth and proliferation of cancer cells. In blood cancers, the drug is often included in lymphodepleting regimens prior to stem cell transplantation or certain immunotherapies.
CLL is one of the most common forms of leukemia and often arises during or after middle age. In CLL, blood cells known as lymphocytes expand abnormally and crowd out healthy blood cells. According to federal statistics, it was estimated that 20,700 individuals would be diagnosed with CLL and 4,440 patients would die of the disease in the United States in 2024.
The FDA rendered its decision on November 19, 2024. Check this resource for updated information on all therapeutics regulated by the FDA.
