Tykerb Combo Gains Accelerated Approval

GlaxoSmithKline received accelerated approval from the FDA for a new combination regimen using Tykerb (lapatinib) as a first-line, 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 overexpresses the HER2 receptor for whom hormonal therapy is indicated.

“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.”

Tykerb was already indicated in combination with Xeloda (capecitabine) for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.