GlaxoSmithKline announced that the US Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using Tykerb (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer.

Tykerb is now indicated in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that over expresses the HER2 receptor for whom hormonal therapy is indicated. Tykerb in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.

“This combination of Tykerb plus Femara is an example of advancing science and improving patient care. This regimen attacks two specific receptors that drive cancer growth,” said Paolo Paoletti, senior vice president, GSK Oncology R&D. “Women battling this disease now have the opportunity to delay the use of traditional cytotoxic-chemotherapy, which is an exciting possibility for them.”

Between 25 and 30 per cent of breast cancers overexpress HER2 receptors1 and 60 to 70 per cent of all breast cancer cases in Europe and the US are HR positive.

Tykerb was already indicated 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.

Tykerb, known as Tyverb in European markets, is currently being reviewed by the EMEA for a comparable indication through a supplemental marketing authorisation.

Lapatinib is an oral small-molecule inhibitor of the HER2/ErbB2 tyrosine kinase receptor.