FDA Gives Breast Cancer Pill
Posted on: Friday, 17 November 2006, 09:00 CST
The U.S. Food and Drug Administration said it will give a priority review of the breast cancer pill Tykerb, meaning a decision could be made in six months.
Pharmaceutical giant GlaxoSmithKline PLC said Tykerb, an oral cancer treatment, was filed for approval in the United States in September. A priority review by the FDA means a decision will be reached within six months of submission.
Glaxo, saying it hopes Tykerb becomes a major oncology force, seeks approval to market Tykerb as a treatment in combination with Xeloda from Roche for breast cancer that has spread to other parts of the body, The Wall Street Journal said Friday.
Some analysts said they believe Tykerb could be a $4-billion-a-year seller but this would depend on its competing against Herceptin, an injected drug from Roche and Genentech used in early stage cancer.
Source: United Press International
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