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GlaxoSmithKine plc has announced today the submission of a New Drug Application to the United States Food and Drug Administration (FDA), for approval to market. Tykerb® (lapatinib ditosylate), in combination with Xeloda® (capecitabine).
The new compound is meant for the treatment of advanced metastatic HER2 (ErbB32) positive breast cancer in women who have received prior therapy, a statement read.
The FDA has already granted fast track status to the compound. To date Tykerb is an investigational drug and has yet to be given approval for marketing by any regulatory body.
Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GlaxoSmithKline said in a statement: “This filing is the result of many years of tremendous research and development work by the scientists at GSK. It is truly an outstanding milestone, especially for the many thousands of women who are facing the devastating effects of advanced breast cancer,â€
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