TUESDAY, March 13, 2007 (HealthDay News) -- GlaxoSmithKline's Tykerb (lapatinib) has been approved by the U.S. Food and Drug Administration to treat advanced breast cancer when other cancer drugs haven't succeeded, the agency said Tuesday.
Tykerb was sanctioned to be used in combination with Xeloda (capecitabine) for people with advanced, metastatic (spreading) cancer that is positive for a protein called HER2. About 8,000 to 10,000 women die from metastatic HER2-positive breast cancer each year, the FDA said.
Tykerb, among a class of drugs called kinase inhibitors, deprives tumor cells of signals they need to grow. But it differs from other cancer drugs in that it actually enters cells and blocks the function of the HER2 protein, the FDA said.
The drug was tested in a trial involving 400 women with advanced or metastatic breast cancer that was HER2 positive. Common side effects included diarrhea, nausea, vomiting, and rash. A small percentage of participants also had a decrease in heart function that may have been characterized by shortness of breath. This condition generally was reversible, the agency said.
To learn more about breast cancer, visit the U.S. National Cancer Institute.