Positive phase III for GSK breast cancer drug

The company now plans to file the drug for marketing approval in the US and Europe in the second half of 2006.

The trial evaluated women with refractory advanced or metastatic breast cancer who have documented HER2 overexpression and whose disease progressed despite treatment with Herceptin as well as other cancer therapies.

An independent data monitoring committee unanimously recommended halting enrollment in the study because it had already exceeded its primary endpoint of time to disease progression for women receiving the combination of Tykerb and capecitabine, marketed by Roche as Xeloda.

All women currently enrolled in the trial will continue to be followed and those who are receiving capecitabine alone will be offered the option of switching to the combination therapy of capecitabine and Tykerb in consultation with their physician.

“We are extremely encouraged by these data which suggest that Tykerb may offer significant benefit as an oral medication in combination with chemotherapy for patients with advanced or metastatic ErbB2 positive breast cancer, and whose disease has progressed on previous treatment regimens, including Herceptin,” said Dr Paolo Paoletti, senior vice president of the Oncology Medicine Development Center, at GSK.