GlaxoSmithKline K.K. has announced the submission of a New Drug Application (NDA) to the Japanese authorities for approval to market lapatinib, its new cancer drug.
The indication for which the company seeks approval is for both monotherapy and for combination treatment with capecitabine for patients with advanced or metastatic HER2 positive breast cancer in women who have received prior therapy including an anthracycline, a taxane, and trastuzumab.
In the US, lapatinib was approved on 13 March in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours over express HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. Lapatinib is now marketed as Tykerb in the US. Marketing applications for Lapatinib have been filed around the world, including the European Union, Switzerland, Canada, Brazil, Australia, and South Korea.
Lapatinib, a small molecule that is administered orally, inhibits the tyrosine kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors. Stimulation of EGFR (ErbB1) and HER2 (ErbB2) is associated with cell proliferation and with multiple processes involved in tumour progression, invasion, and metastases. Over expression of these receptors has been reported in a variety of human tumours and is associated with poor prognosis and reduced overall survival.