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FDA Panel Recommends Approval of Roferon-A for Treatment of CML

FDA Panel Recommends Approval of Roferon-A for Treatment of CML

WASHINGTON--The FDA's Biological Response Modifiers Advisory Committee unanimously recommended approval of Hoffmann-La Roche Inc.'s Roferon-A (interferon alfa-2a, recombinant) for the treatment of adult patients with Philadelphia chromosome positive chronic myelogenous leukemia (CML). The interferon is currently approved for use in hairy cell leukemia and AIDS related Kaposi's sarcoma.

A large randomized study suggests that Roferon-A slows progression, elicits more cytogenetic responses, and improves survival in these patients. It is currently designated as an orphan drug for CML, since only 2,500 patients a year are affected with the disease.

 
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