FDA approves Celgene's Pomalyst for advanced multiple myeloma

11 February 2013

The US Food and Drug Administration on Friday approved biotech firm Celgene’s (Nasdaq: CELG) Pomalyst (pomalidomide) to treat patients with multiple myeloma, a form of blood cancer, whose disease progressed after being treated with other cancer drugs. The news pushed Celgene’s stock up 2.4% to $100.13 by close of trading on Friday, and a further $0.17 to $100.30 in after-hours business.

“Pomalyst is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, adding: “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.”

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