Oct 30 2007
The Food and Drug Administration (FDA) in the U.S. has given approval for a new drug to treat chronic myeloid leukemia (CML).
The drug Tasigna (nilotinib), made by Novartis, will be used with patients who are resistant or intolerant to other therapies.
CML is one of the most common forms of leukemia and almost 5,000 people each year are diagnosed with the disease in the U.S. alone.
Some of these sufferers have become resistant to or cannot tolerate the standard therapy for CML, which is Glivec (imatinib).
Novartis says Tasigna, which is taken twice daily, targets a protein that is produced only by cells that have an abnormal chromosome in people with Philadelphia chromosome-positive CML.
The protein is a key cause of the over-production of the white blood cells that characterizes this form of CML.
Novartis says side effects of Tasigna which include rash, nausea, fatigue, headache, constipation, diarrhea, and vomiting, have been reported with the drug and users are advised to avoid food two hours before and one hour after taking it.
The European Union is also expected to approve Tasigna by the end of the year; the drug is already approved in Switzerland and applied for approval in Japan in June.
Tasigna will compete against Bristol-Myers Squibb 'Sprycel' and could replace Glivec in some situations.
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