GSK To Seek Approval of Breast Cancer Drug
Posted April 4, 2006 8:26 a.m. EDT
RESEARCH TRIANGLE PARK, N.C. — Based on Phase III clinical trial results,
plans to file for regulatory approval of a drug that combats advanced or metastatic breast cancer later this year.
GSK said Monday it had halted enrollment in the trial of the drug Tykerb after a pre-planned analysis of interim results from 321 patients showed "statistically significant results exceeding the primary endpoint".
The decision to halt further enrollment in the trial was based on a unanimous recommendation by an independent data monitoring committee, GSK said.
Tykerb was used in conjunction with the chemotherapy drug Xeloda vs. use of Xeloda alone in women whose cancer had advanced despite receiving earlier treatment.