Novartis Submits Applications for Gleevec as First-Line CML Therapy

EAST HANOVER, New Jersey—Novartis 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.