FDA GRANTS PRIORITY REVIEW FOR REVLIMID

The FDA has granted a priority review to Celgene's supplemental new drug application (sNDA) for Revlimid (lenalidomide) for the treatment of relapsed or refractory multiple myeloma.

Celgene seeks approval to market the drug in combination with dexamethasone as a proposed indication for the treatment of multiple myeloma-patients who have received at least one prior therapy. Under the priority review, the firm expects the FDA to make a decision on its sNDA by June 30.

In December 2005, the FDA approved Revlimid for treatment of patients with transfusion-dependent anemia caused by low- or intermediate-1-risk myelodysplastic syndromes (MDS), a collection of bone marrow disorders that result in deformed or underdeveloped red blood cells.