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FDA Approves Celgene's Drug Pomalyst for Blood Cancer

Update Date: Feb 09, 2013 04:57 PM EST

Celgene's drug Pomalyst, (pomalidomide) for multiple myeloma has received federal approval for treating patients who have stopped responding to other drugs for the cancer, the Food and Drug Administration announced on Friday.

Multiple myeloma is a type of blood cancer that arises from cells in the bone marrow- the soft tissue found inside bones that helps make blood cells. Estimated cases of this cancer in 2012 were 21,700. Mostly, this cancer is diagnosed in older people.

The newly approved drug is expected to inhibit cancer growth in people who aren't responding to other drugs for the cancer, FDA said.

The company that makes the drug- Celgene- told Reuters Health in an email that the drug would cost around $10,500 per cycle, and that a patient would require about five cycles for effective treatment. According to Celgene's chief executive, the company expects to earn about a $1 billion from sales of Pomalyst.

 "Treatment for multiple myeloma is tailored to meet individual patient's needs, and today's approval provides an additional treatment option for patients who have not responded to other drugs," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research.

Pomalyst is the second drug to be approved this year for this type of blood cancer and is among the class of drugs that includes lenalidomide and thalidomide, he added.

The drug can cause blood clots.  FDA said that the drug would come with a boxed warning that it should not be used by pregnant women as it can cause birth-defects.

The efficacy of the drug was tested on a group of more than 200 patients suffering from multiple myeloma and weren't responding to other drugs. These patients were divided into two groups with each participant receiving either Pomalyst alone or Pomalyst with low-dose dexamethasone, a corticosteroid.

Study results showed that some 7.4 percent of patients treated with Pomalyst recovered either fully or partially from the cancer compared with 29.2 percent in the Pomalyst with low-dose dexamethasone group. 

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