Celgene wins Chinese regulatory OK for Revlimid

Mon Feb 11, 2013 7:35pm IST

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(Reuters) - Celgene Corp on Monday said its drug Revlimid won full regulatory approval in China for patients with relapsed or refractory multiple myeloma, a type of cancer that starts in the plasma cells in the bone marrow.

Multiple myeloma is the second most commonly diagnosed blood cancer. There are an estimated 750,000 people with the disease worldwide, according to the International Myeloma Foundation.

Celgene said it expects the drug to be available to Chinese patients late in the second quarter of 2013.

In addition, the biotechnology company said Revlimid, or lenalidomide, was granted priority review by the U.S. Food and Drug Administration as a treatment for patients with relapsed or refractory mantle cell lymphoma.

Revlimid is approved in combination with dexamethasone for the treatment of patients with multiple myeloma, who have received at least one prior therapy, in almost 70 countries, including the Americas and Europe.

It is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anemia.

(Reporting By Debra Sherman; Editing by Gerald E. McCormick)

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