US approves one-a-day pill for advanced breast cancer

WASHINGTON -- Women with an aggressive form of advanced breast cancer that other treatments have failed to stop gained a new option yesterday with the approval of a novel drug -- but how much benefit it offers is unclear.

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 company said. The Food and Drug Administration said it approved Tykerb for use in conjunction with the chemotherapy drug Xeloda.

Glaxo said 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 eight and a half 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, Glaxo said a later analysis 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 Xeloda alone.