Deaths force Celgene to stop Revlimid CLL trial in its tracks

Revlimid churns out the cash for Celgene ($CELG). Some $3.8 billion last year, in fact. And to keep the breakthrough blood-cancer drug on a growth path, the company is toiling over research on new uses. Sometimes that works, as it did with last week's study in patients newly diagnosed with multiple myeloma.

But sometimes it doesn't. Today, Celgene said it had halted a trial testing Revlimid as a first-line treatment for elderly patients with B-cell chronic lymphocytic leukemia, or CLL. The reason: almost twice as many deaths in Revlimid patients as in control patients.

FDA put the ORIGIN study on a clinical hold last week, Celgene said, after data showed that 34 of the 210 patients in the Revlimid arm died, compared with 18 of 211 patients using chlorambucil. "No specific causality for this imbalance has been identified," the company said in a statement.

Revlimid accounted for 68% of Celgene's total 2012 revenue. Originally approved in 2005 as a treatment for anemia associated with myelodysplastic syndromes, the drug's use expanded in 2006 to multiple myeloma, which now accounts for most of its sales. Last month, it won FDA's blessing for certain mantle cell lymphoma patients. It's ready for launch in China, too. And along the way, it has grown by leaps and bounds, with 34% growth just since 2010.

The company has staked a lot of time and money on adding new Revlimid indications. But it has some other up-and-coming drugs; its breast-cancer drug Abraxane won a new approval in lung cancer last year, a new use that could add $1 billion to its sales. It's planning to ask the FDA to approve Abraxane for pancreatic cancer this year. And its latest multiple myeloma drug, Pomalyst, won FDA approval in February, a key advance. CEO Bob Hugin is betting the new product can help propel Celgene to $12 billion in sales by 2017.

A Revlimid approval in CLL would have helped considerably, too. The company is still studying the drug in patients with the disease, but clinical investigators will be notified about the halted ORIGIN trial and told to inform patients as well.

- read the release from Celgene

Special Reports: Bob Hugin - Celgene - The 25 most influential people in biopharma | Celgene: The house that Revlimid built | The Biggest R&D Spenders in Biotech

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