FDA Approves New Indication For Roferon-A in CML Patients

ROCKVILLE, Md--The Food and Drug Administration has approved anew indication for Roche Laboratories' Roferon-A (interferon alfa-2Arecombinant). The agent, previously approved for use in treatinghairy cell leukemia and AIDS-related Kaposi's sarcoma, is nowalso indicated for the treatment of chronic phase, Philadelphiachromosome positive chronic myelogenous leukemia (CML).

The treatment is intended for patients who have been either previouslyuntreated or minimally pretreated, preferably within 1 year fromdiagnosis.

"Roferon-A will provide many CML patients with another treatmentalternative, especially those for whom bone marrow transplantationis not an option," said Robert Armstrong, vice president,Medical Affairs, Roche Laboratories.

In a randomized study supporting the new indication, Roferon-Atherapy significantly prolonged the median survival of CML patientsby 14 months, compared with conventional chemotherapy, eitherhydroxyurea or busulfan (69 months in the Roferon-A arm vs 55months for conventional single-agent chemotherapy). In this trial,intermittent single-agent chemotherapy was allowed for insufficienthematologic response to Roferon-A alone, and 44% of the Roferon-Atreated patients also received this therapy at some time duringthe study.

Cytogenetic Responses

In addition, Roferon-A treatment slowed disease progression andelicited a higher cytogenetic response (disappearance of the Philadelphiachromosome) than did conventional treatment.

Patients with partial hematologic response should be treated forat least 18 months to maximize the possibility of a complete response,the company said. Treatment with Roferon-A should be continueduntil disease progression. Achievement of complete cytogeneticresponse has been observed up to 2 years following the start oftreatment with Roferon-A.

The FDA's recommended dosage of Roferon-A for treatment of CMLis 9 million IU administered daily as a subcutaneous or intramuscularinjection.

The most common side effects associated with the agent are fever,fatigue, myalgia, and chills, and 23% of patients were withdrawnfrom the randomized CML study because of these effects.