On Oct. 19, 2006, the U.S. Food and Drug Administration (FDA) granted Glivec® (imatinib) has received US regulatory 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.  The drug is known as Gleevec® (imatinib mesylate) tablets in the U.S.

With this decision, and in only five years, Glivec has now been approved in the US for seven diseases, including two solid tumors and five blood disorders with molecular targets known to be inhibited by the drug.

The FDA approvals are based on data from Novartis-sponsored clinical studies and clinical data from independent medical researchers showing the efficacy of Glivec in treating these diseases, in which there is a suggested connection between a Glivec-sensitive pathway and the disease.

Glivec targets the activity of proteins called tyrosine kinases that appear to play important roles within some cancer cells. Glivec 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 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) – and the receptor tyrosine kinase Kit in Kit-positive GIST (gastrointestinal stromal tumor).