Novartis announced that the European Commission (EC) approved Glivec (imatinib) as a first-line treatment for adult and pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), enabling physicians to provide the drug to newly diagnosed patients. This third approval in late December 2002 comes within 14 months of the initial approval of Glivec in the EU and follows a positive opinion from the EU's Committee for Proprietary Medicinal Products (CPMP) received in September 2002.
The EC's approval of Glivec as first-line therapy for adult patients was based on 12-month data from a large head-to-head study comparing Glivec with a combination of interferon-alpha and cytosine arabinoside (IFN/Ara-C), a traditional treatment for CML. In the International Randomized Study of Interferon vs. STI571 (IRIS), patients treated with Glivec - given oral, Pennsylvania, and indicated even better results than the 12-month data used to support the approval. The updated 18-month data have not been reviewed by the health authorities.