NOVARTIS' GLEEVEC APPROVED FOR FIVE NEW CANCER INDICATIONS

Novartis' Gleevec (imatinib mesylate) has received FDA approval to help patients with five distinct and potentially life-threatening disorders, representing the first time that a regulatory authority has ever simultaneously approved one targeted medicine for so many disorders, according to Novartis. Gleevec has now been approved in the U.S. for seven diseases. The approvals are based on data from Novartis-sponsored clinical studies and clinical data from independent medical researchers showing the efficacy of Gleevec in the treatment of these diseases, in which there is a suggested connection between a Gleevec-sensitive pathway and a disease.

Gleevec targets the activity of proteins called tyrosine kinases that appear to play important roles within some cancer cells. Gleevec has been shown to inhibit the function of the tyrosine kinase Bcr-Abl in patients with certain forms of blood cancer -- Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and Ph+ acute lymphoblastic leukemia (ALL) -- and the receptor tyrosine kinase Kit in Kit-positive gastrointestinal stromal tumors (GISTs). Researchers have found Gleevec also inhibits other tyrosine kinases, including platelet-derived growth factor receptor, which have been shown to be activated in disease pathways that underlie a number of rare hematologic diseases, as well as some solid tumors.

The new diseases for which Gleevec received approval are: dermatofibrosarcoma protuberans (DFSP), a type of tumor that begins as a hard lump found in the skin of the chest, abdomen or leg; relapsed/refractory Ph+ ALL; certain forms of myelodysplastic/myeloproliferative diseases (MDS/MPD), which involve certain blood cells made in the bone marrow; hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL), which is characterized by the persistent overproduction of eosinophils; and aggressive systemic mastocytosis (ASM), which is marked by the presence of too many mast cells.

An approval for newly diagnosed patients is still under review by the FDA. In the European Union (EU), Gleevec was recently approved for treatment of certain patients with Ph+ ALL as well as for adult patients with a form of DFSP. The EU is also reviewing applications for approval of Gleevec as a treatment for MDS/MPD, HES/CEL and ASM.