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 achieved an 83%
major cytogenetic response rate, compared to 20% for the combination of
interferon-alpha and 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.