GSK seeks regulatory approval in U.S., Europe for Tykerb

GlaxoSmithKline on Monday said it has submitted its experimental breast cancer drug Tykerb, which is taken orally, for FDA approval and plans to file for approval in Europe in the fourth quarter of this year, Reuters reports (Reuters, 9/18).

Tykerb 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 tested Tykerb in combination with Xeloda, a chemotherapy drug, in 160 women living with breast cancer and compared them with 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.

The trial was stopped early because it "became unethical" to give some women only Xeloda.

According to some experts, 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, 6/5).

Tykerb is formulated to be used in combination with Xeloda to treat late-stage breast cancer (Reuters, 9/18).

FDA has granted Tykerb "fast-track" status, which is given to drugs that aim to treat diseases considered serious and a designation that expedites regulatory review, Dow Jones reports (Greil, Dow Jones, 9/18).

The approval process for drugs given fast-track status usually takes about six months, Raleigh News & Observer reports (Vollmer, Raleigh News & Observer, 9/19).