GSK Applies For E.U. Approval Of Late-Stage Breast Cancer Drug Tykerb

GlaxoSmithKline on Monday announced that it has filed an application with the European Medicines Agency to sell its experimental breast cancer drug Tykerb in combination with Roche's chemotherapy drug Xeloda in the European Union, the AP/Houston Chronicle reports (Wardell, AP/Houston Chronicle, 10/9). Tykerb is taken orally and is formulated to be used in combination with Xeloda to treat late-stage breast cancer. The drug targets the cells that drive certain types of breast cancer and does not affect healthy cells. Charles Geyer of Allegheny General Hospital in Pittsburgh and colleagues earlier this year presented a study to the American Society of Clinical Oncology that tested Tykerb in combination with Xeloda among 160 women living with breast cancer. Researchers also enrolled 161 women living with breast cancer who were treated with Xeloda alone. The study finds that tumors in women receiving combination therapy did not grow for 8.5 months, while tumors in women who took only Xeloda began to grow in 4.5 months. FDA last month granted GSK "fast-track" status on its application for U.S. approval of Tykerb, which usually takes about six months. Some experts have said that Tykerb has not yet been shown to increase the life expectancy of women and is not effective in all women (Kaiser Daily Women's Health Policy Report, 9/19). GSK in a statement said that it aims to submit applications for Tykerb's approval in Australia, Canada and several other countries worldwide by the end of 2006 (AP/Houston Chronicle, 10/9). According to London's Daily Mail, if the European Medicines Agency approves the application, the drug could be available in the United Kingdom by June 2007. In addition, further research could garner approval for the drug as a treatment for earlier-stage breast cancer within two years, the Daily Mail reports. Trial data has shown the drug could help prevent and treat the spread of advanced breast cancer to the brain and could be effective in treating kidney and liver cancers, the Daily Mail reports (Daily Mail, 10/8). GSK CEO Jean-Pierre Garnier said the company hopes to establish a "pricing strategy" for the once-daily Tykerb pill "that will not be an obstacle to patients but will also give a return to shareholders" (Sunderland, Observer, 10/8).

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View drug information on Tykerb; Xeloda.