GlaxoSmithKline’s cancer drug Tykerb, combined with chemotherapy drug Xeloda, shows promise in helping women with advanced breast cancer, according to a new study published Thursday in the New England Journal of Medicine.

Tykerb has yet to win regulatory approval.

“There has been a clear need for alternative treatments to help women with metastatic breast cancer in this advanced setting,” said Charles Geyer, director of medical oncology at Allegheny General Hospital in Pittsburgh, Pa. “[Tykerb] combined with [Xeloda] has demonstrated superior efficacy over [Xeloda] alone in this group of patients, and we look forward to it being made available to women suffering from this devastating disease.”

The study showed no increase in serious toxicity or in the number of women choosing to discontinue treatment when compared to treatment solely with Xeloda. Adverse effects included diarrhea, hand-foot syndrome and rash distinct from hand-foot syndrome.

Metastatic breast cancer kills more than 400,000 women a year around the world.

"We are extremely enthusiastic that NEJM has chosen to publish this important data, which we believe will truly change the treatment paradigm for thousands of women suffering from late stage breast cancer," said Paolo Paoletti, who is senior vice president of GSK’s Oncology Medicine Development Centre. "It is also exciting news that these results suggest there may be a role for Tykerb in the earlier treatment of breast cancer.”

GSK maintains two headquarters in the U.S., one in Philadelphia and the other in Research Triangle Park, N.C.