ARTICLE | Clinical News

Glivec regulatory update

January 30, 2012 8:00 AM UTC

EMA's CHMP issued a positive opinion to expand the label of Glivec imatinib from Novartis to include treatment of adult patients following surgical removal of stem cell factor ( SCF) receptor tyrosine kinase (c-Kit; KIT; CD117)-positive gastrointestinal stromal tumors (GIST) for 36 months. The BCR-ABL tyrosine kinase inhibitor is approved in the EU to treat adult patients with unresectable and/or metastatic malignant KIT-positive GIST and for the adjuvant treatment of adult patients who are at significant risk of relapse following resection of KIT-positive GIST. Glivec is also approved for Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL), as well as myelodysplastic syndrome (MDS), myeloproliferative diseases and certain other cancer indications. ...