-- GlaxoSmithKline plc announced today that the United States Food and Drug Administration (FDA) approved TYKERB(R) (lapatinib), in combination with Xeloda(R) (capecitabine), for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress 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.
"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, MD, Senior Vice President of the Oncology Medicine Development Center at GSK. "The approval of TYKERB demonstrates our R&D organization's strong commitment to the discovery and development of novel cancer treatments. We are dedicated to the further study and development of Tykerb in a variety of settings including adjuvant breast cancer as well as in other solid tumor types."
This approval reflects more than 16 years of research, including more than 60 clinical trials and investigator-initiated collaborative research studies. 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. As a targeted therapy, TYKERB is designed to interfere with discrete cellular processes or disease mechanisms prevalent in cancer. TYKERB will be available in the United States within two weeks and, as an oral therapy, offers added convenience for patients.
GSK finished today's trading down 42 cents at 54.83 per share. Monoclonal antibody treatments are gaining in popularity due to their target specificity. It remains to be seen if TYKERB has the same cardiac side effects as herecptin.See post from January 9th for more info on herceptin and breast cancer.
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