EAST HANOVER, New JerseyNovartis has simultaneously submitted marketing
applications with health authorities in the United States and the European
Union seeking marketing authorization for Gleevec (imatinib mesylate) for the
first-line treatment of newly diagnosed Philadelphia-chromosome-positive
chronic myeloid leukemia (CML), the company said in a news release.
The filings are based on data from the International Randomized Study of
Interferon vs STI571 (IRIS), which were presented at the 2002 ASCO annual
meeting. Gleevec is currently approved in the United States for the treatment
of patients with Ph-positive CML in the blast crisis, accelerated phase, or
chronic phase after failure of interferon-alfa therapy.