ODAC to review carfilzomib for multiple myeloma
San Francisco based Onyx Pharmaceuticals is announcing that the US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has agreed to review the company's recently submitted New Drug Application (NDA) for carfilzomib. Onyx is seeking marketing approval for carfilzomib for the treatment of relapsed and refractory multiple myeloma (MM) in patients who have received at least two prior therapies.
Mulitple myeloma is a cancer of the plasma cells typically in bone marrow. There is currently no cure for MM. Approximately 80,000 new cases of the disease are diagnosed worldwide each year.
Carfilzomib is a late-stage, next-generation proteasome inhibitor currently being evaluated in several clinical trials.
Says Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals, "Multiple myeloma is a deadly disease for which there are no cures, and we are committed to bringing carfilzomib to patients as quickly as possible,"
ODAC has agreed to review the NDA when it meets on 20 June 2012.
Source: Therapeutics Daily
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