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| |  Roferon-A Cleared for Marketing by FDA NUTLEY, N.J., Oct. 20, 1995 -- Roche Laboratories today announced that Roferon(R)-A has received marketing clearance from the U.S. Food and Drug Administration (FDA) for the treatment of chronic phase Philadelphia chromosome positive chronic myelogenous leukemia (CML). This new indication specifies treatment with Roferon-A in patients either previously untreated or minimally pretreated, preferentially within one year from diagnosis. "Roferon(R)-A will provide many CML patients with another treatment alternative, especially those for which bone marrow transplantation is not an option," said Robert Armstrong, Vice President, Medical Affairs, for Roche Laboratories. Roferon(R)-A therapy significantly prolonged the median survival of CML patients by 14* months compared to conventional chemotherapy (hydroxyurea or busulfan). In addition, Roferon(R)-A treatment slowed disease progression and elicited a higher cytogenetic response. CML accounts for 20-25% of all adult leukemias and, according to the Leukemia Society of America, occurs in 5,000 patients each year in the U.S. According to Moshe Talpaz, M.D., professor of medicine and chairman, Department of Bioimmunotherapy at M.D. Anderson Cancer Center in Houston and lead investigator for the DM 84-38 clinical trial, "Treatment with interferon alfa-2a in CML patients has resulted in a significant survival advantage and increased cytogenetic response compared to patients who received raditional chemotherapy treatment. A positive correlation also exists between the length of time a patient remains on interferon alfa-2a therapy and the cytogenetic response achieved," continued Dr. Talpaz. Cytogenetic response is achieved when Roferon(R)-A (interferon alfa-2a) causes the abnormal cell (Philadelphia chromosome positive) to disappear, sometimes completely. In an exploratory analysis, patients who achieved a cytogenetic response lived longer than those who did not. Cytogenetic responses were observed only in patients who had complete hematologic responses. CML CML is characterized by progressive leukocytosis, anemia, marrow hypercellularity and splenomegaly. Historically, CML occurs in three phases (chronic phase, accelerated phase and blast crisis). The majority of patients are diagnosed in the chronic phase. In approximately 90% of patients suffering from CML, a distinctive chromosomal translocation (the Philadelphia chromosome) is found in up to 100% of proliferating marrow cells at the time of diagnosis. After a median time of 2.5-4 years, a more aggressive and almost invariably fatal form of CML develops. The median time from the end of chronic phase to blast crisis is 4-6 months, with about 75% of patients going through an accelerated phase and 25% abruptly progressing to acute phase or blast crisis. After onset of blast crisis, survival is measured in months. Dosage The recommended dosage of Roferon(R)-A (interferon alfa-2a, recombinant) for CML is 9 million international units (MIU) administered daily as a subcutaneous or intramuscular injection. Roferon(R)-A also is indicated for use in the treatment of hairy cell leukemia and AIDS-related Kaposi's sarcoma. Studies have shown that Roferon(R)-A can produce clinically meaningful tumor regression or disease stabilization in patients with these diseases. Side Effects As with other interferon treatments, the most common side effects associated with Roferon(R)-A include fever, fatigue, myalgia and chills. Severe adverse events were observed in 66% and 31% of patients in studies DM 84-38 and MI400, respectively. However, only 15% and 22% of the patients were withdrawn because of adverse events in these two studies. The significant survival advantage and the unique biologic activity observed in the patients treated with Roferon(R)-A may outweigh the risk of treatment-related toxicity and therefore would allow a large proportion of patients to benefit from Roferon(R)-A treatment. Treatment with Roferon(R)-A should be continued until disease progression. About Roche Laboratories Roche Laboratories is the pharmaceutical sales and marketing division of Hoffmann-La Roche Inc., and has a strong history in the area of oncology with 5-FU and Roferon(R)-A (interferon alfa-2a, recombinant). One of the world's leading research-intensive health care companies, Roche has discovered, developed and introduced numerous important prescription pharmaceuticals. The company is also a major provider of diagnostic products and services as well as vitamins, premixes and other products for human and animal nutrition and health. * 48 percent of Roferon(R)-A-treated patients also received intermittent, single agent chemotherapy at some time during the study. CONTACT: Alfred Wasilewski, 201-562-2231; home, 201-762-7545; or e-mail: Alfred.Wasilewski@roche.com
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