(By Balachander) Celgene Corp. (NASDAQ: CELG) said China health regulators have approved its Revlimid drug for treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
The Summit, New Jersey-based biopharmaceutical company said the China State Food and Drug Administration (SFDA) granted full approval for Revlimid.
Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from plasma cells in the bone marrow. According to the National Cancer Institute, about 21,700 Americans are diagnosed with multiple myeloma and 10,710 die yearly from the disease.
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The company expects Revlimid to be available late in the second quarter of 2013.
In addition, Celgene said the U.S. Food and Drug Administration (FDA) accepted its application for Revlimid in patients with relapsed or refractory mantle cell lymphoma (MCL) after prior therapy that included bortezomib. The agency has set a Prescription Drug User Fee Act date of June 5, 2013.
On Friday, the company said the FDA has approved an oral therapy to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.
The stock, which has been trading in the 52-week range of $58.53 to $102.29, rose 1.67 percent in premarket trading on Monday.