Novartis cancer drug wins US approval in record time
The Novartis healthcare group in Basel says its breakthrough oral cancer drug, Glivec, has been approved in record time by the United States authorities.
The company said the drug had proven extremely effective against a rare but deadly type of leukaemia.
Glivec helped about 90 per cent of patients in early stages of chronic myeloid leukaemia (CML), a disease that causes a potentially lethal overproduction of white blood cells, Novartis said.
The US health and human services secretary, Tommy Thompson, said at rare news conference to announce a drug approval in Washington that Glivec was an outstanding medical breakthrough.
"It appears to change the odds dramatically for patients, and it does so with a relatively low occurrence of side effects," he said.
Glivec, a once-a-day pill, is the first in a new class of drugs which strike a specific target believed to cause cancer.
Praising the scientists and researchers who work on anti cancer drugs, Thompson added: "We believe many more products will follow based on the years of scientific groundwork that has already taken place."
The Food and Drug Administration said it reviewed the Novartis application in two and a half months, a record time for a cancer medicine. Glivec is expected to be available by the end of the month.
The FDA said it approved Glivec after reviewing three studies involving about 1,000 patients. An FDA statement said the studies showed Glivec treatment could "substantially reduce" levels of cancerous cells in bone marrow and blood.
Novartis said its studies showed that white blood cell counts returned to normal in nearly 90 per cent of early CML patients who were not responding to treatment with the drug "interferon". Further studies are planned to determine whether the drug extends patients' survival.
Commenting on the new drug, Novartis chairman and chief executive Daniel Vasella said it was gratifying that his group's researchers had discovered the new therapy.
"Based on the dedicated efforts of my Novartis colleagues and a constructive collaboration with the FDA, we have succeeded in bringing this revolutionary drug to the patients in record time," he said.
Novartis has submitted filing applications for Glivec to health authorities in the European Union, Switzerland, Canada, Australia and Japan.
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