GSK's Tykerb under EMEA review

UK-based drug major GlaxoSmithKline says that it has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) seeking clearance to market Tykerb (lapatinib ditosylate) as an addition to Roche's anticancer agent Xeloda (capecitabine) as a treatment for breast cancer. Specifically, the firm is is seeking approval for use of the combined regimen in patients with advanced or metastatic HER2-positive breast cancer, who have failed prior therapy.

The drug is a small-molecule dual-receptor tyrosine kinase inhibitor that is administered as a tablet, and is currently under investigation as a therapy for a range of solid-tumor oncology indications. In combination trials with Xeloda, the agent increased the average time-to-disease progression to 26.7 weeks, compared with the 19.1 weeks achieved by Xeloda alone. GSK added that, earlier this year, an independent data monitoring committee recommended that the firm stop enrollment in the study based on the early success of the program, which exceeded its primary endpoint (Marketletter April 10).

Paolo Paoletti, senior vice president of GSK's Oncology Medicine Development Center, said that the Tykerb filing, which is the firm's third oncology drug to be submitted to the EMEA this year-including Hycamtin (topotecan) for cervical cancer and Atriance (nelarabine) for blood cancers, will present patients with a new, effective treatment option. The company added that it plans to file the drug with additional regulators worldwide by the end of the year.