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Cancer pill speeds through testing

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Restoring patients' health

'Fast track' designation

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EAST HANOVER, New Jersey (CNN) -- It could be one of the fastest drug approvals ever: a pill, called Glivec, that's shown astonishing results in patients with a common form of leukemia. Pharmaceutical company Novartis is filing for marketing approval with the U.S. Food and Drug Administration after only three years of study and development. The process usually takes an average of five to seven years.

"We believe this is the fastest from first dose in man to filing," said David Epstein, the president of Novartis Oncology. "What the agency has told us is that they view this as a very important new drug, which has benefits that are not seen in current cancer agents and they're going to work with us very closely to review it as fast as possible."

Novartis is so optimistic that its plant in Europe is working around the clock to produce supplies of the drug.

"When we started studying it in 1998, frankly, it worked much better than we ever anticipated -- the first 31 patients had (a) 100 percent response rate, which is unheard of in the field of cancer or leukemia," said Epstein. "Once we saw that data we put all resources against the product. We can now make tons of the product but the company took an extraordinary risk, investing quite a bit of money early on, a lot of manpower early on and there were no guarantees when the trials finished we'd see the same results."

Results in expanded trials that include 1,230 patients with chronic myelogenous leukemia (CML) -- a common form of the adult cancer -- are not as good as the initial trial, but are still dramatic. In 88 percent of patients their white blood cell counts fell to normal levels. Almost half the patients had what's called a cytogenic response -- the genetic defect for the disease was reduced or could not be seen. Absence of the defect could indicate a cure, but the longest any patient has taken the pill is less than three years. When patients are cancer-free for at least five years, they're considered cured.

Restoring patients' health

"What's so dramatic about this new treatment is that it's a pill people take daily," said Dr. Brian Druker, Oregon Health Sciences University, who has been leading studies of Glivec. "We're restoring the patients to really good health and a lot of the patients are telling me that they're feeling better than they have in years."

Novartis has yet to complete phase 3 trials, which are considered the most extensive and complete studies. The company says that's not unusual for some diseases like HIV and cancer.

"It's typically when the unmet medical need is so enormous and the benefit of the drug is so clear that you want to make the drug available as soon as possible," added Epstein. "We made sure these trials were done to the highest possible standards so that when we go out and commercialize, we'll be able to give physicians clear instructions on how to dose the drug, what the response rates are likely to be, what the side effect profile is."

Side effects have been minimal and include nausea, muscle cramps and fluid retention. Researchers say the mild side effects and encouraging results are due to the fact that Glivec is a targeted cancer therapy. Glivec is the first indication that this type of research is paying off.

"Standard chemotherapy treatments kill both normal cells and cancer cells," said Druker, "and this new treatment was designed specifically for this leukemia, just to attack the leukemia cells."

'Fast track' designation

Worldwide, about 5,000 leukemia patients are now taking Glivec experimentally. Studies of the drug are also underway in patients with prostate, lung and brain cancer, as well as patients with a rare form of stomach cancer.

According to Novartis, the FDA has given the drug a "fast track" designation. So it's possible that, only three years after the first patient tried it, Glivec could be on the market for the treatment of leukemia by the end of 2001. The company is also optimistic that approvals could soon come in Switzerland and Japan.



RELATED STORIES:
Researchers report promising results with leukemia treatment
May 22, 2000
Researchers: Pill has potential to destroy leukemia
December 3, 1999
Drug offers hope in battle against leukemia, other cancers
October 26, 1999
Living standards and childhood leukemia
August 7, 2000

RELATED SITES:
Leukemia Research Foundation
Chronic Myelogenous Leukemia (CML)
American Society of Clinical Oncology
The Leukemia and Lymphoma Society
Novartis
Oregon Health Sciences University

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