The FDA ( Food and Drug Administration ) approved Tykerb ( Lapatinib ) in combination with Femara ( Letrozole ) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated. HER2 is a protein involved in normal cell growth. It is found on some types of cancer cells, including breast cancer cells.

In hormone positive breast cancer, the presence of certain hormones contributes to breast cancer growth. In HER2-positive breast cancer, stimulation of the HER2 receptor contributes to cancer cell growth. Breast cancer is the second leading cause of death among women.

Women with HER2-positive disease receiving the Tykerb plus Femara combination more than doubled the time they lived without the cancer progressing compared with those receiving Femara alone ( 35 weeks vs 13 weeks ).

Tykerb enters the cell and blocks the function of the HER2 protein.

Tykerb was initially approved in combination with a chemotherapy drug, Xeloda ( Capecitabine ) in 2007. This combination was used to treat women with advanced breast cancer tumors with the HER2 protein who had received prior treatment with chemotherapy drugs, including an anthracycline and a taxane, and Herceptin ( Trastuzumab ), an anti-cancer antibody used to treat HER2-positive advanced breast cancer.

Safety information from this study was consistent with previous Tykerb clinical studies in advanced breast cancer. The most commonly reported side effects of the combination were diarrhea, rash, nausea and fatigue. Treatment with Tykerb 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: FDA, 2010

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