GSK Reports Positive Results On Breast Cancer Drug Trial, Plans To File For Regulatory Approval In U.S., Europe

GlaxoSmithKline on Monday announced a positive outcome from the Phase III trial of its breast cancer drug Tykerb, which is taken orally, and said it plans to file for regulatory approval in the U.S. and Europe later this year, the AP/Washington Post reports. GSK initially planned to launch three Phase III clinical trials for Tykerb this year and had not scheduled a filing date. However, the company ended enrollment in the drug trials after interim data of 321 patients in the study showed "statistically significant results," the company reported. "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 [Genentech's] Herceptin," which is given intravenously, Paolo Paoletti, senior vice president of the Oncology Medicine Development Center, said in a statement (AP/Washington Post, 4/3).


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View drug information on Herceptin; Tykerb.