NEJM publishes late-stage data for GlaxoSmithKline's Tykerb in HER2-positive breast cancer

Phase III study results published in the NEJM suggest that GlaxoSmithKline's experimental drug Tykerb (lapatinib) in combination with Roche's Xeloda (capecitabine) is "superior" to Xeloda alone for some women with HER2-positive advanced breast cancer. Interim data from the study were previously announced in 2006.

The trial involved women with locally advanced or metastatic HER2-positive breast cancer whose disease had progressed following treatment with therapy that included trastuzumab, which Roche sells as Herceptin. Patients were randomised to receive either a combination of Tykerb and Xeloda, or Xeloda alone. The findings showed that in patients receiving the combination treatment, the median time to disease progression was 8.4 months, compared to 4.4 months for patients treated with Xeloda alone.

Study researcher Dr. Charles Geyer commented that "it's logical to think that Tykerb might also work in earlier stages of [breast cancer] similar to Herceptin," CNN Money reports. He added that "it's reasonable to think that Tykerb could be an alternative to Herceptin, or it could make it work better in earlier stages."

Tykerb is currently under regulatory review in the US and the EU for the treatment of HER2-positive advanced breast cancer, in combination with Xeloda, for patients who have received prior therapy.

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