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FDA approves expanded use of GSK's Tykerb

The FDA has approved an expanded use of GSK's breast cancer treatment Tykerb (lapatinib) when used in combination with Femara (letrozole)

The US Food and Drug Administration (FDA) has approved the use of GlaxoSmithKline (GSK)'s Tykerb (lapatinib) in combination with Novartis' Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

"This drug combination of Tykerb plus Femara provides women being treated for advanced breast cancer with an important treatment option. This entirely oral treatment regimen works by targeting both HER2 and the hormone receptors, thereby slowing the cancer cells' ability to grow or spread," said Dr Richard Pazdur, director of the Office of Oncology Drug Products, in the FDA's Center for Drug Evaluation and Research.

Paolo Paoletti, senior vice president of GSK Oncology R&D said: "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 Roche's oral chemotherapy 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, which is known as Tyverb in Europe, is currently being reviewed by the European Medicine's Agency (EMEA) for a comparable indication through a supplemental marketing authorisation.

1st February 2010

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