Revlimid lenalidomide regulatory update

FDA said it will update the label of Celgene's Revlimid lenalidomide to include a warning that the drug is associated with an increased risk of developing new cancers in newly diagnosed multiple myeloma (MM) patients, specifically acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS) and Hodgkin's lymphoma. In April 2011, FDA began a safety review of Revlimid after receiving reports that the thalidomide analog may be associated with an increased risk of second primary malignancies (see BioCentury, April 18, 2011). Celgene markets Revlimid in the U.S. in combination with dexamethasone to treat MM in patients who have received >=1 prior therapy and to treat patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS. ...