Celgene Corporation (Nasdaq: CELG) announced that the U.S. Food and Drug Administration (FDA) has granted approval for its Supplemental New Drug Application (sNDA) for an additional indication for REVLIMID (lenalidomide), for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. REVLIMID is also approved for use in the treatment of patients with transfusion-dependent anemia due to Low-or- Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Multiple myeloma is the second most common blood cancer in the United States, affecting approximately 50,000 people. About 14,600 new cases of multiple myeloma are diagnosed each year and about 12,000 Americans are expected to die of multiple myeloma in 2006. In the REVLIMID (lenalidomide)/dexamethasone treatment group, 151 patients (45%) underwent at least one dose interruption with or without a dose reduction of REVLIMID (lenalidomide) compared to 21% in the placebo/dexamethasone treatment group. Most adverse events and Grade 3 or 4 adverse events were more frequent in patients who received the combination of REVLIMID (lenalidomide)/dexamethasone compared to placebo /dexamethasone.
'The FDA approval of REVLIMID offers a new oral therapeutic option to this particular group of patients with multiple myeloma,' said Graham Burton, M.D., SVP, Regulatory Affairs and Pharmacovigilance for Celgene. REVLIMID will be available in the following strengths: 5 mg, 10 mg, 15 mg, and 25 mg capsules.