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FDA Approves New Late-Stage Breast Cancer Drug

The Food and Drug Administration (FDA) has approved GlaxoSmithKline’s breast cancer drug Tykerb for treatment of women with late-stage breast cancer who have exhausted other treatment options. When taken with the chemotherapy drug Xeloda, Tykerb has been shown to stop the growth of tumors for eight-and-a-half months, while tumors in women who were only taking Xeloda began to grow again in four-and-a-half months. FDA approval comes after 16 years of research and more than 60 clinical trials and research studies.

Len Lichenfeld, the deputy chief medical officer of the American Cancer Society, said, “We now have a new drug that offers promise and hope to women who have a more aggressive form of breast cancer, where until very recently we had little to offer,” Newsday reports.

GlaxoSmithKline has not yet announced pricing information for the drug, but analysts expect the treatment will cost patients about $3,600 monthly. The company has announced that its low-income patient assistance will be expanded so that those who have household incomes at or below 500 percent of the federal poverty line and without health insurance will be able to get the drug at no cost, according to Kaiser Daily Women’s Health Policy Report. Additionally, assistance will be given to those in the Medicare prescription drug benefit program.

Despite the money-centered nature of the pharmaceutical industry, the Philadelphia Inquirer reports that Tykerb is not likely to become “a major revenue driver for many years” for GlaxoSmithKline.

Tykerb should be available within two weeks.

Sources:

Philadelphia Inquirer 3/14/07; GlaxoSmithKline release 3/13/07; AP 3/14/07; Kaiser Daily Women's Health Policy Report 3/14/07; Newsday 3/14/07

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