New Cancer Drug Produces Striking Results

In an early trial, 23 of 24 CML patients treated with the drug were in complete remission within a month, based on blood cell counts. In a more recent trial, 89% of patients with unresectable or metastatic GIST had marked clinical improvement. These results led to an approval by the U.S. Food and Drug Administration (FDA) after a review of only two and a half months, making this the fastest time to market of any cancer treatment to date. Shipments of the drug from the warehouse have already begun.

Called Gleevec (formerly ST1571), the drug is intended for the treatment of patients with CML in the blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy, and for GIST. Doctors believe that it may also be effective against glioblastoma. Effectiveness to date is based on overall hematologic and cytogenetic response rates. As yet, no controlled trials have demonstrated a clinical benefit, such as improvement in disease-related symptoms or increased survival.

Gleevec represents a new type of antiproliferative agent called a signal transduction inhibitor (STI), which has been shown to have the potential to interfere with intracellular signaling pathways that have implications in tumor development. Gleevec is believed to target the activity of certain enzymes called tyrosine kinases located within the cell. The drug is marketed by Novartis AG (Basel, Switzerland), which is now supplying the drug free of charge to 7,500 patients around the world in countries where the drug is not yet sold.




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