Company Watch

GSK gets FDA nod for cancer drug

Our News Bureau - Mumbai

GlaxoSmithKline received an approval for Tykerb (lapatinib), in combination with Xeloda (capecitabine), for the treatment of patients with advanced or metastatic breast cancer whose tumours over express HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. It is the first targeted, once-daily oral treatment option for this patient population. Tykerb was granted priority review by the FDA in November 2006.

"Metastatic breast cancer is one of the leading causes of cancer deaths in India. Treatment options for advanced breast cancers are very limited at present. The approval of lapatinib by the USFDA on a fast track basis is a clear indication of the high degree of relevance of this drug in the treatment of metastatic breast cancer in a select patient population," said Dr Sadhna Joglekar, Vice-President, Medical and Clinical Research, GlaxoSmithKline India.

"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 recurred despite treatment with previous therapies, including anthracyclines, taxanes and trastuzumab," said Paolo Paoletti, MD, Senior Vice-President of the Oncology Medicine Development Centre at GSK. This approval was based on data from a Phase III study reporting that Tykerb (lapatinib) plus Xeloda (capecitabine) is superior to capecitabine alone in women with HER2 (ErbB2) positive advanced breast cancer who had progressed following prior therapy, including Herceptin (trastuzumab), published in the New England Journal of Medicine.