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Celgene wins China's blessing for Revlimid launch

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Celgene's Revlimid won an approval from Chinese regulators.--Courtesy of Celgene

Celgene's ($CELG) blood cancer drug Revlimid is on a roll. Already a blockbuster with $3.77 billion in 2012 sales, Revlimid has snagged an approval from Chinese regulators. And the FDA put the drug up for priority review for a new use in patients with mantle-cell lymphoma.

As Dow Jones reports, the Chinese approval comes with an import license, and Celgene expects to launch Revlimid there in the second quarter. It's approved as an add-on treatment to dexamethasone, for patients who've already failed on at least one therapy.

Meanwhile, in the U.S., the FDA is expected to decide by June 5 on Revlimid's use in mantle-cell lymphoma, a rare blood cancer. It's already approved in combination with dexamethasone in previously treated multiple myeloma patients, and for patients with anemia caused by myelodysplastic syndromes.

First approved in the U.S. in 2006, Revlimid galloped to blockbuster status and continues to grow by double-digit percentages. Last year, sales leapt by 17%, partly because patients are staying on the drug for longer periods of time. Celgene is accumulating data for a first-line indication in multiple myeloma, with new survival data coming this quarter. It's also recruiting for new late-stage trials in non-Hodgkin's lymphoma and chronic lymphocytic myeloma.

- see the Dow Jones story (sub. req.)

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