FDA Warns of Revlimid Link to Second Cancers


The U.S. Food and Drug Administration (FDA) has warned treatment of multiple myeloma with the prescription drug lenalidomide—which is marketed and sold by Celgene Inc. under the brand name Revlimid—has been linked to an increased risk of new cancers.

The FDA and Celgene stated that the label and medication guide for this potentially dangerous pharmaceutical will be updated to reflect the increased risk revealed by three trial studies of newly diagnosed multiple myeloma patients. The trials demonstrated that newly diagnosed patients who use Revlimid as a maintenance therapy face a greater risk of developing a second primary cancer.

The drug’s FDA approval was based on trials involving relapsed and refractory myeloma patients, who did not show a significant increase in risk for new cancers. However, the FDA’s analysis of three maintenance trials showed that there had been 65 second primary malignancies among 824 Revlimid patients and 19 among 665 patients whose treatment did not include Revlimid.

Second primary cancers include acute myelogenous leukemia, Hodgkin lymphoma and myelodysplastic syndromes.

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