Novartis has submitted marketing applications with health authorities in the European Union and the United States simultaneously, seeking marketing authorization for Glivec (imatinib) for the first-line treatment of patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML).

In Switzerland, Glivec has already been granted an accelerated approval process for this indication and a complete dossier will be submitted within the next month.

The filings come just over one year following the initial approval of Glivec by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Philadelphia chromosome-positive (Ph+) CML in the blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy, on 10 May 2001. Glivec has been approved for this CML indication in more than 65 countries.

In addition, in February 2002, just nine months following the initial CML approval, Glivec received FDA approval for the treatment of patients with Kit (CD 117) positive unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumours (GISTs). This indication has also been recently approved in the European Union and in Switzerland.