BOSTON — A Food and Drug Administration advisory panel has voted to recommend that the agency approve Celgene Corp.’s oncology drug Revlimid, the company said Wednesday.
By Val Brickates Kennedy, MarketWatch
Last Update: 1:19 PM ET Sept. 14, 2005
Trading in shares of Summit, N.J.-based Celgene was halted at $52.91
Wednesday morning, ahead of the meeting. Celgene is seeking to have the drug Revlimid approved for the treatment of transfusion-dependent anemia due to certain blood cancers known as myelodysplastic syndromes.
Although the panel’s vote is not a final decision, the FDA traditionally
abides by the recommendation of its expert panels.
Celgene said that the FDA is scheduled to formally rule on whether to
approve Revlimid by Oct. 7. The company already markets a version of thalidomide called Thalomid, for the treatment of leprosy, and Alkeran, a treatment for the cancer multiple myeloma.