Novartis' Glivec gains EU approval

The European Commission has granted European Union-wide marketingauthorization for Novartis' Glivec (imatinib) as an oral therapy for the treatment of adult patients with Philadelphia chromosome (Bcr-Abl)-positive chronic myeloid leukemia in chronic phase after failure of interferon-alfa therapy, or in accelerated phase or blast crisis.

The application for marketing approval was based on Phase I and II data from more than 1,000 patients participating in a global clinical trials program. The effectiveness of Glivec was measured in terms of hematologic and cytogenetic response rates.

Glivec, also marketed as Gleevec, is already available in more than 35 countries, including the USA, Brazil, Switzerland and Australia.