ROCKVILLE, Md., March 13 (UPI) -- GlaxoSmithKline on Tuesday won U.S. regulatory approval of Tykerb for use against advanced cases of breast cancer.
The approval by the Food and Drug Administration means Tykerb (lapatinib) can be used in combination with capectabine (Xeloda) for patients with advanced, metastatic breast cancer tumors that exhibit HER2 protein. The combination is indicated for women who previously have been given other cancer drugs, such as an anthracycline, a taxane and trastuzumab (Herceptin).
The American Cancer Society says 8,000-10,000 women die of metastatic HER2 positive breast cancer annually.
"Today's approval is a step forward in making new treatments available for patients who have progression of their breast cancer after treatment with some of the most effective breast cancer therapies available," said Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research in Rockville, Md.
In a randomized clinical trial, half the 400 patients receiving Tykerb with capecitabine showed statistically significant improvement compared to those who received only capecitabine. The tumor response rate also was higher in those receiving Tykerb with capecitabine. The survival data are not yet mature, the FDA said.
