GSK seeks FDA OK for Tykerb as advanced breast cancer treatment

Published: 19-Sep-2006
Regulatory

GlaxoSmithKline (GSK) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval to market Tykerb (lapatinib ditosylate), in combination with Xeloda (capecitabine), for the treatment of advanced or metastatic HER2 (ErbB2) positive breast cancer.


GlaxoSmithKline (GSK) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval to market Tykerb (lapatinib ditosylate), in combination with Xeloda (capecitabine), for the treatment of advanced or metastatic HER2 (ErbB2) positive breast cancer.

The Indication would be for women who have received prior therapy, including Herceptin (trastuzumab). 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, and is currently being investigated in breast cancer and other solid tumours. It is an investigational drug and has not been approved for marketing by any regulatory body.

The company plans to submit the Marketing Authorization Application in Europe during the 4th quarter of this year.

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