FDA Approves New Breast Cancer Combo

31 January 2010 (Last Updated January 31st, 2010 18:30)

The US Food and Drug Administration (FDA) has granted accelerated approval for a new first-line combination to treat breast cancer using GlaxoSmithKline's (GSK) Tykerb (lapatinib) as a first-line, all-oral treatment. Tykerb will now be available in combination with letrozole for the treat

The US Food and Drug Administration (FDA) has granted accelerated approval for a new first-line combination to treat breast cancer using GlaxoSmithKline's (GSK) Tykerb (lapatinib) as a first-line, all-oral treatment.

Tykerb will now be available in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that over expresses the HER2 receptor, for which hormonal therapy is indicated.

GSK Oncology R&D senior vice president Paolo Paoletti said that this regimen attacks two specific receptors that drive cancer growth.

"Women battling this disease now have the opportunity to delay the use of traditional cytotoxic chemotherapy, which is an exciting possibility for them," Paoletti said.

Tykerb, also known as Tyverb in European markets, has already been approved in combination with Xeloda (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.