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news.The FDA has approved GlaxoSmithKline's cancer drug Tykerb in combination with Roche's Xeloda for the treatment of patients with advanced or metastatic breast cancer who have failed standard chemotherapy.
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The drug is the first targeted, once-daily oral treatment option for patients who have progressed beyond the standard treatment which includes anthracyclines, taxanes and Herceptin (trastuzumab). Tykerb inhibits two validated targets in oncology, the kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors, commonly associated with cancer cell proliferation and tumor growth. The drug will be available in the US within two weeks.
“Tykerb is a significant breakthrough for women with advanced HER2 (ErbB2) positive breast cancer. The data clearly show that this small molecule, oral, targeted agent, in combination with capecitabine, is effective for women whose disease has progressed on previous therapies, including anthracyclines, taxanes and trastuzumab,” said Paolo Paoletti, senior vice president of the oncology medicine development center at GSK.
GlaxoSmithKline has also initiated a phase III trial for Tykerb in squamous cell carcinoma of the head and neck.