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

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

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