GSK Submits TYVERB(R)/TYKERB(R) (lapatinib) for First-Line Treatment of Metastatic Breast Cancer in ... ( LONDON and PHILADELPHIA April 1 /- Gl...)

GSK Submits TYVERB(R)/TYKERB(R) (lapatinib) for First-Line Treatment of Metastatic Breast Cancer in Europe, US

Date:4/1/2009

LONDON and PHILADELPHIA, April 1, /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today announced the submission of two simultaneous regulatory applications to expand the use of TYVERB(R)/TYKERB(R) (lapatinib). If approved, TYVERB(R)/TYKERB(R) could be used as a first-line therapy regimen combined with anti-hormonal therapy for patients with hormone-sensitive, metastatic (or advanced) breast cancer in Europe and the United States.

The variation to the EU marketing authorization and the supplemental New Drug Application (sNDA) were submitted respectively to the European Medicines Agency (EMEA) and to the U.S. Food and Drug Administration (FDA) for the combination of TYVERB/TYKERB plus an aromatase inhibitor based on the recent study, EGF30008. This study evaluated TYVERB/TYKERB in combination with letrozole in women whose breast cancer expressed was hormone receptor positive (HR+) and may or may not also over-expressed the HER2+/ErbB2+ receptor.

These data were presented at the San Antonio Breast Cancer Symposium in December 2008.

Breast cancer tumors which initially respond to anti-hormonal therapy such as letrozole can become resistant to treatment, leading to disease progression and ultimately, patient death.1 Between 60-70 percent of all breast cancer cases in Europe and the U.S. are HR+.2

"Tyverb/Tykerb with a hormone therapy is a biologically-rational targeted treatment, since the combination attacks two specific receptors that drive the cancer growth," said Debasish Roychowdhury, MD, Head, Medicines Development, GSK Oncology. "If approved the combination could provide a cytotoxic chemotherapy-free option for these patients and we look forward to working with regulatory agencies to advance the availability of this regimen as a new, oral option for patients in first-line breast
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