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.