FDA grants accelerated approval for GlaxoSmithKline's TYKERB

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. 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 overexpresses 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 percent of breast cancers overexpress HER2 receptors and 60 to 70 percent of all breast cancer cases in Europe and the U.S. are HR positive.

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.

TYKERB, known as TYVERB in European markets, is currently being reviewed by the EMEA for a comparable indication through a supplemental marketing authorization.