FDA Updates Revlimid Label to Warn of Second Cancers

FDA Updates Revlimid Label to Warn of Second CancersThe U.S. Food & Drug Administration (FDA) announced yesterday that new warnings would be added to the label of Revlimid (lenalidomide) regarding an increased risk of second cancers. According to the FDA’s announcement, studies conducted after Revlimid was approved found that newly diagnosed patients treated with the drug may be at risk of developing new malignancies, including acute myelogenous leukemia, a type of blood cancer, myelodysplastic syndromes (bone marrow conditions) and Hodgkin lymphoma.

Revlimid is marketed by the U.S. pharmaceutical company Celgene. It is approved to treat patients with multiple myeloma, a bone-marrow cancer in combination with Decadron (dexamethasone). Revlimid is also approved to treat myelodysplastic syndromes.

The research evaluated by the FDA as part of a Revlimid safety review announced last year included an analysis of three studies in newly diagnosed multiple myeloma patients who received therapy with Revlimid or a placebo following a course of chemotherapy, or chemotherapy and a blood stem cell transplant. According to the FDA, 65 new primary cancers were reported among the 824 patients treated with Revlimid, compared to 19 cases in the 655 given a placebo.

According to the FDA, new safety information regarding the risk of secondary primary malignancies has been added to the Warnings and Precautions section of the Revlimid drug label. The patient Medication Guide is also being updated to inform patients about this risk.

The agency is advising healthcare professionals to consider both the potential benefit of Revlimid and the risk of second primary malignancies when deciding to treat patients with this drug, and monitor patients for this risk. Patients should discuss any questions or concerns regarding Revlimid with their healthcare provider.

Just last week, Health Canada, the FDA’s Canadian counterpart, announced that information regarding the risk of second cancers would be added to the Revlimid label in that country. In Canada, Revlimid can only be prescribed to patients who are registered in and meet all of the conditions of the RevAid program, which is a controlled distribution program for the drug.

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