Little Orange Pill Gets Green Light

The FDA approved the drug Gleevec in world-record time — just a two and a half months — to treat a rare form of leukemia called chronic myeloid leukemia(CML), reports CBS News Correspondent Sharyl Attkisson.

And scientists hope the orange cancer pill will eventually do much more.

"This is a very good day in our struggle against cancer," said Dr. Richard Klausner, director of the National Cancer Institute.

Dr. Brian Drucker conducted the first Gleevec tests on humans, and found remarkable results. "This is an amazing treatment that is going to make a dramatic difference in the odds for CML leukemia patients."

Health and Human Services Secretary Tommy Thompson said the drug is based on the principle of molecular targeting, killing leukemia cells while leaving normal white cells alone.

"We believe such targeting is the wave of the future," he said.

The results of clinical trials of the drug, formerly known as STI-571, generated excitement among cancer researchers.

In clinical trials financed by the manufacturer, Novartis Pharmaceuticals, more than 90 percent of patients in the first phase of CML saw their cancer go into remission within the first six months of taking the pill. The findings were presented in December at a meeting of the American Society of Hematology.

In the trials, white blood cell counts for most chronic patients returned to normal within weeks. In half, the genetic mutation that caused their disease — disappeared.

"In that three month time, I went from being having a hard time even getting out of bed some days to going back to work full time, just basically picking up my life," said Suzanne Dreger, a leukemia sufferer and Gleevec patient.

A study published last month in the New England Journal of Medicine found that long-term treatment with Gleevec appeared to cripple the cells responsible for CML.

The early success ha propelled researchers to test the drug on almost 3,000 patients around the world.

"This is not a miracle drug," but it is a model for future cancer study because it targets the cause of the disease without damaging other cells, Edward Benz, president of the Dana-Farber Cancer Institute at Harvard Medical School, said at the hematology meeting.

Gleevec blocks a signal that the abnormal protein sends out, preventing the abnormal growth and production of other cancerous cells.

Currently the only treatments for CML are bone marrow transplants, which can be dangerous, or interferon, which can extend a leukemia patient's life by up to two years but can have side effects that cause about 20 percent of patients to stop using it.

Gleevec has been studied on humans for only about two years, so how long it will prolong a patient's life is not yet known. But it has had few side effects.

Gleevec will cost patients $2,000 a month or more — about the same as traditional treatments. But in an unusual move, the drug maker Novartis will give it away free to people making less than $45,000 a year and sell it to others on a sliding scale. It will be in U.S. pharmacies in about a week.

"Although the long-term benefits of the drug are not yet known, early studies have shown that Gleevec will offer a significant improvement for many patients," said FDA acting Commissioner Bernard Schwetz.

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