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| |  FDA Approves Lapatinib/Letrozole for Hormone-Positive, HER2-Positive Advanced Breast Cancer ROCKVILLE, Md -- February 1, 2010 -- The US Food and Drug Administration (FDA) has approved lapatinib (Tykerb) in combination with letrozole (Femara) to treat hormone positive and human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated. “This drug combination of [lapatinib] plus [letrozole] provides women being treated for advanced breast cancer with an important treatment option,” said Richard Pazdur, MD, Office of Oncology Drug Products, in the FDA’s Center for Drug Evaluation and Research, Rockville, Maryland. “This entirely oral treatment regimen works by targeting both HER2 and the hormone receptors, thereby slowing the cancer cells’ ability to grow or spread.” Women with HER2-positive disease receiving the lapatinib plus letrozole combination more than doubled the time they lived without the cancer progressing compared with those receiving letrozole alone (35 weeks vs 13 weeks). Women in the study were randomised to receive lapatinib plus letrozole or letrozole alone. It is too early to determine whether an improvement in overall survival will be observed in the clinical trial. Safety information from this study was consistent with previous lapatinib studies in advanced breast cancer. The most commonly reported side effects of the combination were diarrhoea, rash, nausea, and fatigue. Treatment with lapatinib also has been associated with decreases in heart function, liver damage, and lung tissue inflammation. Fetal harm may occur if used to treat advanced breast cancer in pregnant women.
SOURCE: US Food and Drug Administration
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