Novartis has submitted marketing applications with health authorities in the United States and Europe, seeking marketing authorization for Gleevec (imatinib mesylate) for the first-line treatment of patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).
The filings are based on data from the International Randomized Study of Interferon vs STI571 (IRIS), which were presented at the 2002 annual meeting of the American Society of Clinical Oncology. The data demonstrate that in the first-line treatment of newly diagnosed CML patients, imatinib(Drug information on imatinib) achieved an 83% major cytogenetic response rate, compared to 20% for the combination of interferon-alpha and cytarabine(Drug information on cytarabine). Imatinib also significantly delayed the time to progression to more advanced stages of CML, compared with the combination.
Gleevec was initially approved by the US Food and Drug Administration (FDA) in May 2001 for the treatment of patients with Ph+ CML in the blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy.