Women with an aggressive form of advanced breast cancer that other treatments have failed to stop gained a new option Tuesday with the approval of a new drug.
The GlaxoSmithKline PLC drug, Tykerb, is to be taken once daily in pill form and is meant for women who have received prior treatment with the intravenous drug Herceptin and older chemotherapy drugs called taxanes and anthracyclines.
The Food and Drug Administration approved Tykerb for use in conjunction with the chemotherapy drug Xeloda. Tykerb would be available in two weeks. It will cost about $2,900 a month, the company said.
The initial results of a study reported last year showed that Tykerb in combination with Xeloda delayed tumor growth for an average of 8 1/2 months, or about twice as long as Xeloda alone. Tykerb worked so well that the international study was stopped early and all participants were offered the drug. However, the later analysis of the results of that study showed the delay actually was closer to nearly seven months for women on both drugs, versus almost five months for those on Xeloda alone.
The FDA said it was too early to know if women taking Tykerb and Xeloda would live longer than those taking the latter drug alone.
Tykerb, like Herceptin, is part of a new generation of cancer medicines that more precisely target tumors without killing lots of healthy cells.
Herceptin has been an important option for many women with advanced, HER2 positive breast cancer, but eventually it stops working and women succumb to the disease.
Both drugs target a protein called HER-2/neu, which tumors make in abnormally large quantities in roughly one-fourth of all breast cancers. While Herceptin targets the outside of the HER2 protein, Tykerb works from the inside of the cell.
Because of that difference, Tykerb works in some HER2 positive breast cancers that have been treated with Herceptin but no longer benefit from the older drug, the FDA said.
Generally, women with HER2 positive breast cancer face a greater risk of disease progression and death. Approximately 8,000 to 10,000 women die from metastatic HER2 positive breast cancer each year, the FDA said.
Xeloda, or capecitabine, is made by Switzerland's Roche Holding AG. South San Francisco-based Genentech Inc. makes Herceptin, also known as trastuzumab.
Eventually, Tykerb could be studied for use with Herceptin. Glaxo is studying Tykerb as a treatment for other cancers.
Expanded use of Tykerb eventually could make it a blockbuster drug for Glaxo, with annual sales approaching or exceeding $1 billion, analysts have said.
The initial results of a study reported last year showed that Tykerb in combination with Xeloda delayed tumor growth for an average of 8 1/2 months, or about twice as long as Xeloda alone. Tykerb worked so well that the international study was stopped early and all participants were offered the drug. However, the later analysis of the results of that study showed the delay actually was closer to nearly seven months for women on both drugs, versus almost five months for those on Xeloda alone.
The FDA said it was too early to know if women taking Tykerb and Xeloda would live longer than those taking the latter drug alone.
Tykerb, like Herceptin, is part of a new generation of cancer medicines that more precisely target tumors without killing lots of healthy cells.
Herceptin has been an important option for many women with advanced, HER2 positive breast cancer, but eventually it stops working and women succumb to the disease.
Both drugs target a protein called HER-2/neu, which tumors make in abnormally large quantities in roughly one-fourth of all breast cancers. While Herceptin targets the outside of the HER2 protein, Tykerb works from the inside of the cell.
Because of that difference, Tykerb works in some HER2 positive breast cancers that have been treated with Herceptin but no longer benefit from the older drug, the FDA said.
Generally, women with HER2 positive breast cancer face a greater risk of disease progression and death. Approximately 8,000 to 10,000 women die from metastatic HER2 positive breast cancer each year, the FDA said.
Xeloda, or capecitabine, is made by Switzerland's Roche Holding AG. South San Francisco-based Genentech Inc. makes Herceptin, also known as trastuzumab.
Eventually, Tykerb could be studied for use with Herceptin. Glaxo is studying Tykerb as a treatment for other cancers.
Expanded use of Tykerb eventually could make it a blockbuster drug for Glaxo, with annual sales approaching or exceeding $1 billion, analysts have said.
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