The U.S.Food and Drug Administration (FDA) at a conference in Washington, approves the new leukemia drug-GLEEVEC, first of its kind that directly removes the sign of a protein known to cause cancer. It is given as an oral treatment for chronic myelogenous leukemia (CML). Other molecular-targeting drugs previously approved by the FDA interfere with proteins associated with other cancers, but not with proteins that directly cause the disease.

Gleevec, was discovered and developed by Novartis Oncology in collaboration with its colleagues. CML is a disease in which too many white blood cells are produced in the bone marrow. In the early stages of CML, most patients do not have any symptoms of cancer,but the disease progresses slowly.

In the chronic phase, bone marrow transplantation is the only known cure. But there are many problems and side effects regarding the tranplantation which makes it more difficult to perform.

Gleevec has produced higher remission rates in comparison to the drug-interferon alfa, in three short-duration, early phase clinical trials.After many clinical trials - the FDA approved Gleevec.

Richard Klausner, M.D., director of the National Cancer Institute, said that he shared in the excitement of people with CML, but he also mentioned several caveats. He said many research questions remain to be answered, such as how long Gleevec will control CML. Does the drug actually cure CML patients? Or, does it delay the onset of moreadvanced forms of the cancer?

According to Klausner, "Gleevec offers proof that molecular targeting works in treating cancer, provided that the target is correctly chosen. The challenge now is to find these targets."

Courtesy: Novartis Oncology
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