Pharmaprojects R&D Pipeline News Feed
GSK's US approval for Tykerb: more positive news for breast cancer
16th Mar 2007
GlaxoSmithKline (GSK) looks set to make a major mark in the breast cancer arena, after its EGFR and HER2 inhibitor, Tykerb (lapatinib ditosylate), received its first approval for this indication this week.
After more than 16 years of research, the US FDA has given the go-ahead for use of Tykerb in combination with Roche's chemotherapy cancer drug Xeloda (capecitabine), for the treatment of patients with advanced or metastatic breast cancer whose tumours express HER2 and who have received prior therapy with an anthracycline, a taxane and Herceptin (trastuzumab). Tykerb was granted a fast-track review by the FDA in November 2006.
Confident that the company will be able to exploit Tykerb's activity in further cancer indications, Paolo Paoletti, MD, Senior Vice President of the Oncology Development Center at GSK said: "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 tumour types".
GSK expects to achieve blockbuster status with this drug after its expected launch in the 1st half of 2007.
