Breakthrough Cancer Drug

The Food and Drug Administration has approved a breakthrough cancer treatment after just under three months of review.

The drug has shown amazing results in treating a deadly form of leukemia and could change the way many other cancers are treated.

For More Info 1-877-GLEEVEC or www.nci.nih.gov

The small pill offers big hope to patients diagnosed with the blood cancer called chronic myelogenous leukemia, or CML.

The drug, which will be sold under the trade name "Gleevec" was put on the fast track for approval after studies showed it was effective in 95 percent of patients with early stages of the disease and in 60 percent of those with advanced cases.

Secretary Tommy Thompson/Health and Human Services: "IT APPEARS TO CHANGE THE ODDS DRAMATICALLY FOR PATIENTS, AND WHAT A WONDERFUL THING TO SAY. AND IT DOES SO WITH RELATIVELY LOW OCCURRENCES OF SERIOUS SIDE EFFECTS."

Patients who use the drug won't have to undergo chemotherapy or deal with needles.

The drug has been engineered in the laboratory to target a single cancer-causing protein and --like a light switch-- turn off its signal to produce leukemia cells.

That enables it to kill leukemia cells while leaving the normal white blood cells alone.

Gleevec is being tested as a treatment for a number of other cancers. It's expected to be available to patients by the end of the month.

CML is a disease in which too many white blood cells are made in the bone marrow, the spongy tissue inside the large bones in the body.

Most of the 4,500 Americans diagnosed with CML each year are middle-aged or older, although the cancer can occur in children. In the first stages of CML, most people do not have any symptoms of cancer, and the disease progresses slowly.

Bone marrow transplantation in the initial chronic phase of the disease is the only known cure for CML. However, many patients are not young or healthy enough to tolerate transplantation or do not have a suitable marrow donor, and the procedure can cause serious side effects or death.

Treatment with the drug interferon alfa may produce remission, restoring a normal blood count in up to 70 percent of patients with chronic phase CML. If interferon alfa is ineffective or patients stop responding to the drug, the prognosis is generally bleak.

Gleevec has produced higher remission rates in three short-duration, early phase clinical trials.

In the results of one clinical trial, reported in April in the New England Journal of Medicine, Gleevec restored normal blood counts in 53 out of 54 interferon-resistant CML patients, a response rate rarely seen in cancer with a single agent. Fifty-one of these patients were still doing well after a year on the medicine, and most reported few minor side effects.