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BeiGene blood cancer drug gets China FDA approval for expanded use

The China Food and Drug Administration approved BeiGene Ltd.'s Revlimid to treat certain patients with a type of blood cancer.

The drug was approved to be used along with dexamethasone in previously untreated adult patients who are ineligible for transplant. Dexamethasone is a corticosteroid medication used to treat many inflammatory and autoimmune conditions.

The approval was based on phase 3 trial data, which showed that significantly more patients who received Revlimid and dexamethasone lived longer without cancer progression, compared to alternative treatments.

Revlimid, also known as lenalidomide, was approved in China in 2013 in adults with previously treated multiple myeloma. BeiGene is marketing the drug under an exclusive license from Celgene Corp.

The drug, in combination with dexamethasone, is already approved in the U.S., Europe, Japan and in about 25 other countries for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Multiple myeloma is the second most commonly diagnosed blood cancer, affecting 750,000 people worldwide, according to the International Myeloma Foundation.