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

June 1, 1995

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.

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.