ARTICLE | Company News

FDA reviewing Revlimid safety

April 12, 2011 12:28 AM UTC

FDA began a safety review of Revlimid lenalidomide from Celgene Corp. (NASDAQ:CELG) after preliminary data from clinical trials showed a potential increased risk for secondary malignancies associated with the cancer drug. The agency said it currently believes the benefits of Revlimid continue to outweigh the potential risks and that it recommends that patients continue treatment as prescribed. The thalidomide analog is approved in the U.S. in combination with dexamethasone to treat multiple myeloma (MM) in patients who have received at least one prior therapy and to treat patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS). Celgene was off $0.56 to $55.36 on Monday. ...