Cancer pill wins marketing approval
ROCKVILLE, Maryland (CNN) -- In what may be one of the fastest drug approvals ever, the U.S. Food and Drug Administration has approved Gleevec for the treatment of chronic myelogenous leukemia (CML) in patients who have failed standard therapy.
Health and Human Services Secretary Tommy Thompson made the announcement Thursday afternoon, calling drugs like Gleevec "the wave of the future."
Gleevec, which was formerly spelled "Glivec" and is also known as STI-571, is a pill that's taken once a day.
"When we started studying it in 1998, frankly, it worked much better than we ever anticipated," said David Epstein, president of Novartis Oncology, which manufactures the drug.
A study recently published in the New England Journal of Medicine showed 51 of 53 CML patients remained in remission one year after treatment. Researchers say while it's possible Gleevec may cure some patients, the benchmark for "cure" is five consecutive years cancer free.
"There are hints cure may be possible," said lead researcher Dr. Brian Druker, of Oregon Health Sciences University. "In at least one patient, leukemia cells could not be detected. If those results continue for a year or two, patients could be taken off treatment."
The American Cancer Society estimates there will be a total of 31,500 new cases of leukemia in the United States this year, including 4,700 cases of CML. It said about 10,000 new cases of CML are expected worldwide.
Gleevec works by seeking out and destroying only cancer cells, while healthy cells remain virtually untouched. So far, patients have reported only minimal side effects including nausea, muscle cramps and fluid retention.
"This is a drug that controls cancer with almost no side effects," said Dr. Harmon Eyre of the American Cancer Society. "So, for us in the world of oncology to have that is a huge breakthrough. It's a great drug, a great new discovery."
The FDA also approved Gleevec to treat patients with two advanced forms of CML known as "accelerated phase" and "blast crisis."
"These are patients in which almost nothing works," said Druker. Although a handful of these patients have experienced remissions that last up to a year, most blast crisis patients relapse within months.
"It's amazing that it's as active in the blast crisis as it is," said Eyre. "Essentially for all practical purposes that disease is basically untreatable. It was completely unexpected in my mind."
Studies show Gleevec also is effective in a second type of cancer called gastrointestinal stromal tumor (GIST), which affects about 2,000 people in the United States every year. A case report of a Finnish woman shows after one year of treatment, there is no sign of the cancer. Expanded trials of the drug in GIST patients will be released later this month at the American Society of Clinical Oncology meeting.
Additional studies will evaluate Gleevec's effectiveness in glioblastoma, a lethal brain tumor, small-cell lung cancer and prostate cancer.
Supplies of the drug are expected to be widely available two weeks following marketing approval.
Submissions for marketing approval have also occurred in the European Union, Canada, Switzerland, Australia and Japan. Results in expanded trials with 1,230 CML patients continue to show promise. So far, Gleevec has been studied in more than 5,000 patients in 30 countries.
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