The Food and Drug Administration has added a warning about second-cancer risk to the label of lenalidomide, a widely used multiple myeloma drug, after a safety review lasting about 1 year.
Treatment with lenalidomide (Revlimid) for newly diagnosed multiple myeloma is associated with almost a threefold increased risk of developing secondary primary malignancies, the agency announcedon May 7. The finding was based on three postapproval trials of lenalidomide as maintenance therapy in newly diagnosed patients.
"Specifically, these trials showed there was an increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma," the FDA said. No increase was seen in incidence of nonmelanoma skin cancers and solid tumors,
It noted that as of Feb. 28, 2011, a pooled analysis showed there were 65 second primary malignancies among 824 patients treated with lenalidomide vs. 19 second primary malignancies among 665 patients in treatment arms that did not include lenalidomide maintenance (7.9% vs. 2.8%, respectively; P less than .001). "The median time from start of Revlimid to a diagnosis of a second primary malignancy was two years," the agency said.