ROCKVILLE, Md--The Food and Drug Administration has approved a new indication for Roche Laboratories' Roferon-A (interferon alfa-2A recombinant). The agent, previously approved for use in treating hairy cell leukemia and AIDS-related Kaposi's sarcoma, is now also indicated for the treatment of chronic phase, Philadelphia chromosome positive chronic myelogenous leukemia (CML).
The treatment is intended for patients who have been either previously untreated or minimally pretreated, preferably within 1 year from diagnosis.
"Roferon-A will provide many CML patients with another treatment alternative, especially those for whom bone marrow transplantation is not an option," said Robert Armstrong, vice president, Medical Affairs, Roche Laboratories.
In a randomized study supporting the new indication, Roferon-A therapy significantly prolonged the median survival of CML patients by 14 months, compared with conventional chemotherapy, either hydroxyurea or busulfan(Drug information on busulfan) (69 months in the Roferon-A arm vs 55 months for conventional single-agent chemotherapy). In this trial, intermittent single-agent chemotherapy was allowed for insufficient hematologic response to Roferon-A alone, and 44% of the Roferon-A treated patients also received this therapy at some time during the study.
In addition, Roferon-A treatment slowed disease progression and elicited a higher cytogenetic response (disappearance of the Philadelphia chromosome) than did conventional treatment.
Patients with partial hematologic response should be treated for at least 18 months to maximize the possibility of a complete response, the company said. Treatment with Roferon-A should be continued until disease progression. Achievement of complete cytogenetic response has been observed up to 2 years following the start of treatment with Roferon-A.