Leukemia drug gets EU approval

The European Commission has granted an EU marketing authorisation for Novartis's Glivec (imatinib) as an oral therapy for the treatment of adult patients with Philadelphia chromosome (Bcr-Abl) positive chronic myeloid leukemia (CML) in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. The approval follows a positive recommendation by the EU's Committee for Proprietary Medicinal Products (CPMP) in July 2001.

Glivec* is currently marketed in more than 35 countries, including the US, Brazil, Switzerland and Australia. This novel therapy is a signal transduction inhibitor, which potentially interferes with the pathways that signal the growth of tumour cells. It inhibits the Philadelphia chromosome, which characterises CML. Traditional approaches to cancer treatment affect not only cancerous cells, but also normal cells, resulting in unwanted side effects. In contrast, says Novartis, Glivec affects a specific component of the cell that is created by a genetic abnormality that causes the growth of cancerous cells.

The Japanese Ministry of Health, Labour and Welfare (MHLW) has also approved the import of Glivec. 'Glivec is a novel drug that offers unprecedented efficacy, and we will have successfully launched Glivec in the US, EU and in Japan in less than seven months', said David Epstein, president, Novartis Oncology.

At the end of November, Novartis also submitted an application to the EMEA for a community marketing authorisation for Glivec for the treatment of gastrointestinal stromal tumours (GISTs) . If approved, this would be the first new treatment option beyond surgery for GI stromal tumours. In addition, Glivec has been designated as an orphan drug in the EU for GIST.

GISTs are the most common malignant form of sarcoma arising in the gastrointestinal tract with around 12,000 new cases each year worldwide. Historically, they have been very difficult to treat due to their high levels of resistance to traditional chemotherapy and radiation therapy. Until now, surgery has been the only treatment option.

Novartis recently submitted a supplemental New Drug Application (sNDA) to the US FDA and the IKS in Switzerland for the use of Glivec in patients with inoperable and/or metastatic malignant GISTs, and additional submissions to other health authorities are under preparation.

'Glivec has shown unprecedented responses in these patients and would represent a major advance in the treatment of this solid tumour,' said Dr David Parkinson, vice president, clinical research, Novartis Oncology.

*Outside the US: Glivec (imatinib); in the US: Gleevec (imatinib mesylate)