Celgene Seeks Approval for Blood Cancer Treatments
From Associated Press (January 4, 2011)
Celgene Corp. said Tuesday it submitted for approval blood cancer treatments Revlimid and Istodax to European and U.S. regulators, respectively.
The Summit, N.J., company is seeking approval for Revlimid from the European Medicines Agency to treat multiple myeloma patients who have not progressed after an initial treatment with melphalan, prednisone and Revlimid or after stem cell transplantation.
Celgene said last month a late-stage study of Revlimid and the chemotherapy dexamethasone showed the combination slowed the progression of symptoms in patients with blood cancer. The company studied the treatment in patients with smoldering multiple myeloma, a slow-growing and rare form of cancer in plasma cells.
Celgene also submitted a supplemental new drug application to
the U.S. Food and Drug Administration last month for Istodax to be
used in treating patients with peripheral t-cell lymphoma who have
already received at least one therapy.
Posted: January 2011