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FDA Approves New Indication For Roferon-A in CML Patients

FDA Approves New Indication For Roferon-A in CML Patients

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

"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 (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.

Cytogenetic Responses

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.


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