FDA News

FDA Approves GSK Late-Stage Breast Cancer Drug Tykerb

(March 13, 2007)--FDA has approved GlaxoSmithKline's breast cancer drug Tykerb in combination with Roche's chemotherapy drug Xeloda as a treatment for women with late-stage breast cancer who have not responded to treatment from other medications, including Genentech's Herceptin, the Wall Street Journal reports. Tykerb is taken orally and is formulated to be used in combination with Xeloda to treat late-stage breast cancer.

The drug targets the cells that drive certain types of breast cancer and does not affect healthy cells. Charles Geyer of Allegheny General Hospital in Pittsburgh and colleagues earlier this year presented a study to the American Society of Clinical Oncology that tested Tykerb in combination with Xeloda among 160 women living with breast cancer. Researchers also enrolled 161 women with breast cancer who were treated with Xeloda alone.

The study found that tumors in women receiving combination therapy did not grow for 8.5 months, while tumors in women who took only Xeloda began to grow in 4.5 months. Some experts have said that Tykerb has not yet been shown to increase the life expectancy of women and is not effective in all women (Kaiser Daily Women's Health Policy Report, 10/11/06). According to the Journal, side effects exhibited with Tykerb include diarrhea; nausea; vomiting; rash; and hand-foot syndrome, which could include tingling, redness, swelling and discomfort in the hands and feet.

GSK declined to give pricing information for the drug, the Philadelphia Inquirer reports. Some analysts said they expect the drug to be priced around the same level as Herceptin, which costs up to $3,600 monthly, or about $44,000 annually. The company announced it will expand its low-income patient program to provide Tykerb at no cost to people without health insurance. Those eligible for the program must have household incomes at or below 500% of the federal poverty level, the company said. The plan also has a component for people in the Medicare prescription drug benefit, the Inquirer reports.

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