Breast Cancer :: Glaxo’s Tykerb helps breast cancer patients

GlaxoSmithKline (NYSE: GSK) announced positive data from three key studies on its first-in-class, oral small molecule HER2 kinase inhibitor, Tykerb (lapatinib).

Results of these and other important Tykerb studies are being presented this week at the 2007 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois.

The use of TYKERB in these settings is investigational.

?The robust clinical data presented for TYKERB at ASCO further demonstrate the great potential of this drug as an essential component of treatment regimens for women with HER2-positive breast cancer,? said Paolo Paoletti, M.D., Senior Vice President of the OncologyMedicineDevelopmentCenterat GSK. ?GSK is dedicated to an ongoing TYKERB clinical programme to identify additional treatment regimens, as well as patient populations that may respond to TYKERB. The data presented at ASCO this week underscore our unrelenting commitment to improving treatment for these patients.?

TYKERB in Combination with Paclitaxel as First-Line Treatment for Patients with Metastatic or Relapsed Advanced Breast Cancer (Abstract #1011, Embargoed until June 3, 15.00 BST)1

Paclitaxel is one of the most commonly used chemotherapies in breast cancer. Therefore, the evaluation of TYKERB in combination with this treatment is of high importance.

This large, randomized, multicenter, prospective trial evaluated a total of 580 patients either negative or untested for HER2 overexpression. While the combination therapy did not demonstrate an incremental benefit for patients with HER2-negative disease, an analysis of 91 patients who were retrospectively identified as having HER2-positive disease showed that TYKERB plus paclitaxel increased progression-free survival in patients with HER2-positive breast cancer not previously treated with trastuzumab.

TYKERB/TYVERB (lapatinib) is a first-in-class oral small-molecule inhibitor of the HER2 tyrosine kinase receptor. Stimulation of HER2 is associated with cell proliferation and with multiple processes involved in tumour progression and metastases. Overexpression of this receptor has been reported in a variety of human tumours and is associated with poor prognosis and reduced overall survival. On March 13, 2007, the United States Food and Drug Administration (FDA) approved TYKERB, in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.

TYVERB was approved in Switzerlandin May 2007. Marketing applications for TYKERB/TYVERB have been filed around the world, including the European Union, Canada, Brazil, Australiaand South Korea.


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