What is GLEEVEC and what is the approved indication?
Gleevec is a therapy that targets the main cause of Chronic Myeloid Leukemia (CML) – the Philadelphia chromosome. Gleevec is indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase. Follow Gleevec is also indicated for the treatment of patients with Philadelphia chromosome-positive CML in blast crisis, accelerated phase, or in chronic phase after failure on interferon-alpha therapy. Gleevec is also indicated for the treatment of pediatric patients with Ph+ CML in chronic phase who are newly diagnosed or whose disease has recurred after stem cell transplant or who are resistant to interferon-alpha therapy. There are no controlled trials in pediatric patients demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. Gleevec is also indicated for adult patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), adult patients wit