Tykerb® (lapatinib), Approved for Metastatic Breast Cancer

In March the FDA announced that it had approved the drug lapatinib (Tykerb®) for the treatment of advanced or metastatic HER2-positive breast cancer in combination with capecitabine (Xeloda®) for women who had undergone previous treatment with other cancer drugs including an anthracycline, a taxane, and trastuzumab (Herceptin®). The drug is taken orally once a day. More...Tykerb is one of a new class of drugs called "targeted therapies" that focus on particular genetically determined cell traits in an efort to improve cancer treatment by focusing on critical abnormalities in an individual patients' cancer. Tykerb works by disabling the function of an important protein called HER2 along with other proteins dependent on HER2 that drive the growth of cancer cells in about 20% of women with breast cancer. The drug has been called a "significant" breakthrough for women with advanced HER2-positive breast cancer and has proven to have a favorable safety and tolerability profile in the metastic setting. Trastuzumab was the first "targeted therapy" approved for the treatment of HER2-positive breast cancer. The combination of Herceptin with chemotherapy reduces the risk of recurrence 4 years after diagnosis by 50%. However, abbout 15% of women still suffer a recurrence or metastasis within 4 years with Herceptin. Tykerb disables the HER2 protein in a different way than Herceptin, so it is now being looked at as an agent for treatment as an adjuvant therapy in early breast cancer. The National Surgical Adjuvant Breast and Bowl Project (NSABP) is undertaking a new clinical trial, which should be active in the summer of 2007. This trial will compare how well women with HER2-positive breast cancer respond to Tykerb with chemotherapy relative to Herceptin with chemotherapy, as well as how they respon d to Tykerb with Herceptin and chemotherapy. It should be noted that Tykerb does not work for all patients. Several cautions should be noted for women who are treated with this drug. Although, as noted above, the drug is relatively safe, it should not be taken with (or taken only under careful monitoring with) antibiotics, antifungals, certain foods (eg, grapefruit), anticonvulsants, drugs like dexamethasone, and homeopathic treatments such as St. John's wort. In some cases the dose can be reduced to accommodate these other agents. Certain patients with pre-existing heart and liver conditions should be evaluated before treatment. In addition, itching, rash, vomiting, diarrhea, acne, and dry skin have been seen in women who take Tykerb. The use of Tykerb for the tretment of metastatic breast cancer and the drug's emergence in the research arena for use in early breast cancer means that women will have more options for the treatment of some of the more aggressive breast cancers. The appearance of this drug is one more example of the additional therapies based on specific genetic targets in individuals that are being developed and may soon be in general use for many different types of cancers. NOTE: This article was written by Charles E. Geyer, Jr., MD, Director, Medical Affairs, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA

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