GSK Seeks Approval Of Advanced Breast Cancer Drug For First-Line Treatment

Main Category: Breast Cancer
Article Date: 06 Apr 2009 - 3:00 PDT

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GlaxoSmithKline on Wednesday applied for approval to market its breast cancer drug Tykerb in U.S. and Europe as a first-line treatment for women with advanced, hormone-sensitive breast cancer, the AP/Google.com reports. Tykerb, known as Tyverb in Europe, was approved two years ago in the U.S. as part of a treatment for HER2-positive, advanced breast cancer that was not treated successfully with chemotherapy and other medications. It is approved for similar use in the 27 European Union countries and other nations. About two-thirds of breast cancer cases are hormone sensitive, which means that the disease is fueled by estrogen produced in the body.

Approval of the application to market the drug as an initial treatment would make Tykerb available to about 5,000 U.S. women for whom it would be appropriate, the AP/Google.com reports. If approved for such use, Tykerb would be administered in combination with another drug that prevents hormones from multiplying cancerous cells. According to Debasish Roychowdhury, head of oncology medicines development at GSK, the drug targets cancer cells more than healthy cells, which could lead to fewer side effects, such as nausea or hair loss. Tykerb can damage the liver and fetuses, the AP/Google.com reports (AP/Google.com, 4/2).

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