Novartis' Gleevec approved in the USA for CML in record time

Novartis' new anticancer drug Gleevec (imatinimab mesylate) has beenapproved as a once-daily oral therapy for patients with chronic myeloid leukemia in blast crisis, accelerated phase or in chronic phase, after failure of interferon alfa therapy, in the USA, its first world market. The company said it hoped to make the drug available in US pharmacies within a week of its May 10 clearance.

The drug was reviewed under the US Food and Drug Administration's fast-track review system in just two and a half months, and went from first dosing in man to approval in less than three years, which Novartis claims is the fastest time to market of any cancer treatment. News of the approval drove Novartis' US-listed shares up 6.8% to $41.

The approval represents something of a landmark in oncology, as Gleevec is the first cancer drug that has been rationally-designed to address a specific aspect of the molecular pathogenesis of a tumor type to reach the registration stage. In this case, the compound addresses a genetic malfunction present in CML patients, in which a reciprocal translocation occurs between chromosomes 9 and 22, resulting in what is described as the Philadelphia chromosome. Gleevec blocks the function of an abnormal protein, called Bcr-Abl, which is produced as a result of the gene mutation and stimulates the uncontrolled proliferation of leukocytes, which is the hallmark of CML.