FDA Grants Approval for New Breast Cancer Drug from GSK

RESEARCH TRIANGLE PARK, N.C. – Tykerb, a drug for treatment of women with advanced breast cancer developed by GlaxoSmithKline, received approval Tuesday from the U.S. Food and Drug Administration.

The drug is to be used in combination with a chemotherapy known as Xeloda.

The combined treatment targets women with advanced or metastatic breast cancer and who have received earlier therapies. Tykerb is taken orally once a day.

Breast cancer was diagnosed in more than 212,000 women in the U.S. in 2006, according to estimates by the American Cancer Society. More than 40,000 women were estimated to die of the disease last year.

 Glaxo, which has dual U.S. headquarters in Philadelphia and Research Triangle Park, North Carolina, said Tykerb would be available in two weeks. It will cost about $2,900 a month, the company said.

The results of a study published 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 when compared to treatment with Xeloda alone, The Associated Press reported. Tykerb worked so well that the international study was stopped early and all participants were offered the drug

Approval of the drug had been widely expected. The FDA granted it priority review status in November.

Paolo Paoletti, an MD and senior vice president of the Oncology Medicine Development Center at GSK, called the drug a “significant breakthrough.”

GSK will also test Tykerb as a potential treatment for use in other cancer cases, Paoletti added.

However, 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.

The lack of that information has left one advocacy group disappointed. Survival - and not progression of disease - gives a truer picture of a cancer drug's efficacy, Barbara A. Brenner, the executive director of Breast Cancer Action, told the FDA in a March 5 letter.

"The FDA should not approve drugs that have not shown either a survival benefit or improved quality of life for breast cancer patients with metastatic disease," Brenner's letter read in part.

FDA drugs chief Dr. Steven Galson said Tykerb expanded the options available to women with a type of advanced breast called HER2 positive when it has metastasized, or spread.

"Today's approval is a step forward in making new treatments available for patients who have progression of their breast cancer after treatment with some of the most effective breast cancer therapies available," Galson said.