Posted on February 2nd, 2010 by
The U.S. Food and Drug Administration (FDA) has expanded its approval of Tykerb® (lapatinib) to include initial treatment of metastatic, postmenopausal breast cancer that is both HER2-positive and hormone receptor-positive. In this setting, Tykerb is approved for use in combination with the aromatase inhibitor drug Femara® (letrozole).
Twenty to thirty percent of breast cancers overexpress (make too much of) a protein known as HER2. Overexpression of this protein leads to increased growth of cancer cells. Fortunately, the development of treatments that specifically target HER2-positive cells has improved outcomes among women with HER2-positive breast cancer. Drugs that target HER2 include Herceptin® (trastuzumab) and Tykerb.
Tykerb was initially approved in 2007 for use in combination with the chemotherapy drug Xeloda® (capecitabine) for the treatment of HER2-positive advanced or metastatic breast cancer that has progressed following prior therapy with an anthracycline, a taxane, and Herceptin® (trastuzumab).
The expansion of Tykerb’s approval to include the initial treatment of metastatic breast cancer was based on a study in 219 postmenopausal women with HER2-positive, hormone receptor-positive, metastatic breast cancer. Women were treated with either Femara alone or Femara plus Tykerb. Both drugs are given orally.
Progression-free survival was 5.2 months longer among women treated with Femara and Tykerb than among women treated with Femara alone.
The most common side effects of Tykerb include diarrhea, rash, nausea, and fatigue.
Reference: FDA News Release. FDA expands use of approved breast cancer drug. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm199374.htm. Accessed February 1, 2010.
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