FDA warns of malignancy risk with Revlimid
The FDA notified the public of an increased risk of second primary malignancies in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide capsules; Celgene). This update is a follow-up to the comprehensive safety review that started in April 2011.
Clinical trials following the approval of Revlimid showed that newly-diagnosed patients treated with lenalidomide capsules had an increased risk of developing second primary malignancies compared to similar patients who received a placebo.
Specifically, these trials showed an increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes and Hodgkin lymphoma. This safety information has been added to the Warnings and Precautions section and the patient medication guide is also being updated to inform patients about this risk.
Lenalidomide capsules are approved for use, in combination with dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. The medication is also approved for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.