Posted by Ted (18.104.22.168) on May 10, 2001 at 19:09:37:
In Reply to: I need some help for a Friend........ posted by TerryS on May 09, 2001 at 20:38:07:
hopefully. I heard about it on All Things Considered today and they also discussed that it looks good for brain tumors, breast cancer, and several others, which they'll be investigating. I hope posting this helps someone out there. My thoughts are with you, Nancy, and your step-granddaughter.
FDA Approves New Leukemia Drug
By RANDOLPH E. SCHMID
.c The Associated Press
WASHINGTON (AP) - A new drug that helped more than 90 percent of patients with a rare form of leukemia won government approval in record time Thursday and was hailed as ``the wave of the future'' in fighting cancer.
Approval of the drug Gleevec by the Food and Drug Administration was announced at a news conference by Health and Human Services Secretary Tommy G. Thompson, an unusual step for such certification.
Gleevec, made by Novartis Pharmaceuticals, is specifically targeted at chronic myeloid leukemia, a disease that claims about 2,300 American lives annually.
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.
Using similar language, Dr. Richard D. Klausner, director of the National Cancer Institute, said, ``This new drug, we believe, is a picture of the future of cancer treatment.''
Dawn Willis, scientific programs director for the American Cancer Society, also praised the approval.
``I can't think of another cancer drug that has shown such spectacular success in a group of people that had failed all other treatment,'' she said. She said the concept of attacking cancer by designing a small molecule that will specifically attack a target protein should be usable in other forms of the disease as well.
Gleevec itself is being tested against about a dozen forms of the disease and researchers are working on other similar targeting drugs.
Dr. Daniel Vasella, president of Novartis AG, the Swiss parent company, said he hopes to begin shipping the drug by next Monday and to have it in pharmacies within a week.
U.S. shares of Novartis were up $3.09, or 8 percent, to $42.09 in afternoon trading on the New York Stock Exchange.
The one-pill-a-day regimen is expected to cost between $2,000 and $2,400 monthly, which company officials said is comparable to other current cancer treatments.
But Vasella said the company is setting up a program to make sure it is available to uninsured, low-income people. He said it would be priced at a sliding scale for people with incomes below $100,000 a year and would be free for those under $40,000 income.
Gleevec works by blocking chemical signals sent by cancerous cells and researchers hope it will also prove useful in a form of stomach tumor and perhaps other types of cancer as well.
The results of clinical trials of the drug, also known as STI-571 or imatinib mesylate, generated excitement among cancer researchers.
Chronic myeloid leukemia is caused by a protein that produces an abnormal chromosome. It leads to a huge increase in the number of white blood cells in the body, which can interfere with the functioning of other organs.
In clinical trials financed by Novartis, 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, according to findings presented in December at a meeting of the American Society of Hematology.
A study of patients in the second phase of the disease showed more than 90 percent of those patients responded positively to the treatment, and in 63 percent, the cancer went into remission. The trials involved 530 first-phase and 230 second-phase patients.
The early success has propelled researchers to test the drug on almost 3,000 patients around the world.
Gleevec blocks a signal that the abnormal protein sends out, preventing the abnormal growth and production of other cancerous cells. It targets three specific signaling chemicals, some of which also are present in other forms of cancer.
Currently the only treatments for CML are bone marrow transplants, which can be dangerous, and 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.
Dr. Bernard A. Schwetz of the FDA termed Gleevec ``an unprecedented drug with a new form of action,'' but stressed that long-term effects remain unknown.
Much remains to be learned as more people use the drug, agreed Klausner, but he said Gleevec ``is as interesting and impressive as any (drug) we have seen in our long war on cancer.''
Suzanne Dreger of Falls Church, Va., testified to its value.
She was diagnosed with CML four years ago and by last year interferon was no longer helping her, she said. Many days she was unable to even get out of bed until she was able to get into a trial of Gleevec, she said.
``It's been a great year for me,'' she beamed, reporting she was back at work and her cancer is near remission.
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