The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee will hold a review of the Celgene Corporation’s new drug application (NDA) for pomalidomide at its meeting on November 8, 2012. The Company is seeking approval to market pomalidomide in combination with dexamethasone as a potential treatment for patients with relapsed and 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.
Pomalidomide is not approved in the US for the treatment of multiple myeloma.
Pomalidomide is an ImiDs compound. Pomalidomide and other IMiDs continue to be evaluated in over 100 clinical trials. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions.
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 that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumours. The cause of the disease remains unknown.
Celgene Corporation is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.