FDA expands approval for GlaxoSmithKline's Tykerb in breast cancer

GlaxoSmithKline announced that the FDA approved its drug Tykerb (lapatinib) in combination with Novartis’ Femara (letrozole) as a first-line treatment for patients with metastatic breast cancer.

The accelerated approval means Tykerb can be used in combination with Femara to treat "hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated," the FDA stated. The agency added that study results demonstrated that patients who received the drug combination lived more than twice as long without their cancer progressing compared with those who received Femara alone.

Tykerb received US approval in 2007 for use in combination with Roche’s Xeloda (capecitabine) as a treatment for advanced or metastatic HER2-positive breast cancer.

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