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New Breast Cancer Drug Petitioning For Initial Treatment Use

April 2, 2009

GlaxoSmithKline PLC has petitioned the U.S. and Europe for permission in to market an already accessible breast-cancer drug as a first-line treatment option.

Tykerb, a British pharmaceutical company, was accepted two years ago as a treatment option. It is available in 27 European Union countries.
Tykerb saw sales of $189 million in 2008 alone. Receiving permission to become an initial treatment would most likely increase sales substantially.

Tykerb is available for women with breast cancer that is HER2-positive.

GlaxoSmithKline now wants to sell Tykerb as a primary treatment option for hormone-sensitive breast cancer. Two-thirds of breast cancer cases are hormone sensitive, powered by the estrogen the body produces.

If approved, Tykerb will be used along with another drug that prevents hormones from making cancer cells multiply. It would be appropriate for about 5,000 American women.

Usually those with hormone-sensitive breast cancer take a hormonal drug that prevents estrogen from affixing to cell receptors and multiplying.
Chemotherapy assaults healthy cells and cancerous ones, producing side effects like vomiting and loss of hair.

Also, “at a certain point in time, the cells don’t respond anymore to the hormonal therapy,” said Dr. Debasish Roychowdhury, head of oncology medicines at GlaxoSmithKline.

Tykerb attaches to HER2 cell receptors, killing the cells to prevent them from multiplying. It normally attacks cancer cells more than healthy cells, Roychowdhury noted.

This means fewer side effects, even though Tykerb can affect the liver and can hurt a fetus.

A study conducted by GlaxoSmithKline in December discovered that in postmenopausal women with advanced breast cancer, Tykerb alongside hormonal treatment Femara, increased cancer survival, weighed against those who took Femara pills alone.

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