The FDA has added new safety information to the label and medication guide for lenalidomide (Revlimid; Celgene), noting that lenalidomide maintenance treatment in patients with newly diagnosed multiple myeloma is associated with an increased risk for developing new primary malignancies. The decision to include this information was based on data from postapproval clinical trials in patients who previously had undergone chemotherapy, either alone or with stem-cell transplantation, before starting maintenance treatment with lenalidomide or with placebo. Of these, 7.9% of lenalidomide recipients compared with 2.8% of placebo recipients were later diagnosed with a myelogenous leukemia, myelodysplastic syndromes, Hodgkin disease, or another new malignancy. The new cancers occurred within 2 years of starting maintenance therapy in half of the affected patients. However, lenalidomide-receiving patients had no increased risk for nonmelanoma skin cancers or solid tumors.
The FDA advises providers to weigh lenalidomide risks and benefits as part of their treatment decisions. Providers need to monitor patients receiving lenalidomide for secondary malignancies. (May 7, 2012)
