GSK SUBMITS NDA FOR BREAST CANCER DRUG
GlaxoSmithKline (GSK) has announced the submission of a new drug application (NDA) to the FDA for approval to market Tykerb (lapatinib ditosylate), in combination with Xeloda (capecitabine), for the treatment of advanced or metastatic HER2-positive breast cancer in women who have received prior therapy. The compound has been granted fast-track status by the FDA in this patient population.
Tykerb is a small-molecule dual-kinase inhibitor developed by GSK as an oral therapy that is currently being investigated in breast cancer and other solid tumors. GSK plans to submit the marketing authorization application for Tykerb in Europe during the fourth quarter of this year.
A Phase III, international, multicenter, open-label trial randomized 324 women who had advanced or metastatic breast cancer with documented HER2 overexpression. In this trial, the combination of Tykerb and Xeloda nearly doubled median time to progression (36.7 weeks) versus with Xeloda alone (19.1 weeks).
In March an independent data monitoring committee made a unanimous recommendation to stop enrollment of the study based on the early success of the trial. The study met its primary endpoint of time to disease progression, and exceeded the predetermined stopping criteria outlined in the committee charter.
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