The FDA authorized Roche Laboratories on Friday toexpand the labeling of its drug, Roferon-A, to includetreatment of chronic phase Philadelphia chromosomepositive chronic myelogenous leukemia (CML).

The agency announced the ruling seven months after theFDA's Biological Response Modifiers Committeeunanimously recommended that FDA permit the labelingchange, noting that the drug helped prolong survival andslow the cancer's spread.

Alfred Wasilewski, Roche's assistant director of publicpolicy and communication said the company has preparedpackage inserts and will immediately begin to promotethe drug for the new indication. "There will be no delay,"Wasilewski told BioWorld Today.

Until now, Roferon-A had been approved only for thetreatment of hairy-cell leukemia and Kaposi's sarcoma.

According to the new indication, the drug may be used totreat patients diagnosed with CML within a year whohave been treated minimally or not at all. It isadministered through daily injections.

So few patients develop CML that Roferon-A, made ofinterferon alfa-2a recombinant, was designated an orphandrug. The Leukemia Society of America estimates thatapproximately 5,000 new cases of CML are diagnosedeach year.

CML destroys leukocytes, ravages the bone marrow andswells the spleen. Patients typically live fewer than fiveyears after the onset of disease. The final phase of thedisease, called blast crisis, is fatal within months.

Until now, the standard chemotherapy involvedmaintenance dosages of bisulfan or hydroxyurea.

Studies at M.D. Anderson Cancer Center, in Houston,and by two European studies found that Roferon-Aincreased survival from 54 months to 69 months,prolonging life by more than a year and slowing theprogression of the disease. Side effects included weightloss, fatigue, body aches and gastrointestinal ailments.

Robert Armstrong, vice president of medical affairs forRoche Laboratories, the sales and marketing division ofHoffman-La Roche Inc. in Nutley, N.J., said Roferon-A"will provide many CML patients with another treatmentalternative, especially those for whom bone marrowtransplantation is not an option." n

-- Steve Sternberg Special To BioWorld Today

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