GlaxoSmithKline seeks U.S. approval for Tykerb

By Elaine Rigoli

Tampa, Fla., Sept. 18 - GlaxoSmithKline plc has submitted a New Drug Application to the Food and Drug Administration for 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).

The compound has been granted fast-track status by the FDA in this patient population.

Tykerb, an investigational drug, is a small-molecule dual kinase inhibitor and is being investigated in breast cancer and other solid tumors.

The London pharmaceutical company said it plans to submit the Marketing Authorization Application in Europe in the fourth quarter.

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