FDA to review Tykerb as breast cancer therapy

UK drug major GlaxoSmithKline says it has submitted a New Drug Application to the US Food and Drug Administration requesting marketing approval for Tykerb (lapatinib ditosylate) as a treatment for breast cancer. Specifically, the NDA covers the agent's use, in combination with Roche's Xeloda (capecitabine), as a therapy for advanced or metastatic HER2 positive breast cancer in women who have failed prior treatments, including Herceptin (trastuzumab), also made by the Swiss firm.

The NDA contains data from a Phase III multicenter trial of the drug in 324 women who had undergone disease progression despite previous treatment. A planned interim analysis of this study revealed that combined Tykerb and Xeloda doubled time-to-disease progression when compared with Xeloda alone (36.7 weeks versus 19.1 weeks).

Data from this trial were originally presented at the American Society of Clinical Oncology meeting in Atlanta, USA, following the recommendation of an independent data monitoring commission that enrollment in the assessment was stopped, based on the early successes that the program achieved.