The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will review Onyx Pharmaceuticals Inc.'s new drug application (NDA) for carfilzomib on June 20 in treating patients with relapsed and refractory multiple myeloma who have received at least two prior therapies.

The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA is July 27.

“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,” said Ted W Love, MD, executive vice president, Research and Development and Technical Operations at Onyx Pharmaceuticals. “Our team looks forward to discussing the potential efficacy benefit and safety profile of carfilzomib with the advisory committee and will continue to work closely with the FDA during its review.”

The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to FDA.

Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow.

Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways.