GlaxoSmithKline Submitted USFDA NDA of Tykerb® (Lapatinib Ditosylate) for Advanced Breast Cancer Treatment
GlaxoSmithKline plc (NYSE: GSK) has recently submitted a New Drug Application (NDA) to the USFDA, seeking approval to market Tykerb® (lapatinib ditosylate), in combination with Xeloda® (capecitabine), for the treatment of advanced or metastatic HER2 (ErbB2) positive breast cancer in women who have received prior therapy, including Herceptin® (trastuzumab).
Tykerb®, a small molecule dual kinase inhibitor developed by GSK as an oral therapy, currently being investigated in breast cancer and other solid tumors, has been granted Fast Track status by the USFDA in this patient population, BUT is an investigational drug that has not been approved for marketing by any regulatory body.
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