US FDA clears new uses for two GlaxoSmithKline drugs; Tykerb and Lamictal; GSK set to announce 3,000 job cuts

UK drug giant GlaxoSmithKline received two pieces of good news from the US Food and Drug Administration last Friday related to its breast cancer drug Tykerb (lapatinib) and Lamictal XR (lamotrigine), currently indicated for epilepsy and for maintenance treatment of bipolar I disorder.

On January 29, the FDA has granted accelerated approval for a new combination regimen using Tykerb as a first-line, all-oral treatment for women with metastatic breast cancer. The drug is now indicated in combination with Swiss drug major Novartis' Femara (letrozole) for the treatment of post-menopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. Tykerb in combination with Femara has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.

"This combination of Tykerb plus letrozole 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, adding: "Women battling this disease now have the opportunity to delay the use of traditional cytotoxic-chemotherapy, which is an exciting possibility for them."