Thursday, June 21, 2012

FDA Advisory Panel Approves Onyx (Nasdaq: ONXX) Blood Cancer Drug

FDA Advisory Panel Approves Onyx (Nasdaq: ONXX) Blood Cancer DrugNorthern, WI 6/21/12 (StreetBeat) -- Shares of Onyx Pharmaceuticals (Nasdaq: ONXX) rocketed Thursday after the company reported that a Food and Drug Administration panel had approved Onyx's Kyprolis for patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy.

Onyx reported late Wednesday that the FDA's Oncologic Drugs Advisory Committee had approved the use of Kyprolis. The committee provides the FDA with independent expert advice and recommendations, but the final decision to approve the drug rests with the FDA itself. The FDA review is expected to be completed by July 27.

Multiple myeloma is the second most common hematologic cancer, or cancer of the blood, according to the Multiple Myeloma Research Foundation. The American Cancer Society estimates that 21,700 cases of multiple myeloma will be diagnosed in 2012.

The Multiple Myeloma Research Foundation hailed the preliminary approval of Kyprolis, the proposed trade name for carfilzomib.

"This is an extremely important endorsement of Kyprolis (carfilzomib) for multiple myeloma patients, as it marks the potential for a new and much-needed treatment option to become widely available for patients with multiple myeloma who are no longer responding to available therapies," the nonprofit organization said in a statement. "Despite the approval of four new treatments between 2003 and 2007, nearly all patients eventually relapse or become refractory to treatment. The five-year relative survival rate for multiple myeloma is approximately 38%, one of the lowest of all cancers, making it critical that we have new treatments like Kyprolis that specifically target these patient populations."

Onyx shares were up 37% in early trading Wednesday at an all-time high near 61.25.

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