FDA Advisory Committee Set to Review Pomalidomide for Multiple Myeloma
Drug is administered with dexamethasone (Sept. 19)
Celgene Corporation, based in Summit, N.J., announced on September 19 that the FDA’s Oncologic Drugs Advisory Committee will review the company’s New Drug Application (NDA) for pomalidomide at its meeting on November 8, 2012.
Celgene is seeking approval to market pomalidomide in combination with dexamethasone as a potential treatment for patients with relapsed or refractory multiple myeloma that has progressed following at least two prior therapies. The agency has set a Prescription Drug User Fee Act (PDUFA) date of Feb. 10, 2013 for completion of the review.
Multiple myeloma — also known as myeloma or plasma cell myeloma — is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells (WBCs) that help produce antibodies called immunoglobulins, which fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein), which does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other WBCs important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.
Pomalidomide is not approved in the U.S. for the treatment of multiple myeloma.
For more information, visit the Celgene Corporation Web site.