GlaxoSmithKline files Tykerb with EU regulators

GlaxoSmithKline submitted investigational drug Tykerb (lapatinib) to the EMEA on Monday. The drugmaker is seeking marketing authorisation for the compound, in combination with Roche's Xeloda (capecitabine), for women with advanced or metastatic HER2-positive breast cancer who received prior therapy, including Roche's Herceptin (trastuzumab).

As part of the filing, Glaxo submitted interim data from a Phase III study involving 324 women with advanced or metastatic HER2-positive breast cancer, whose disease had progressed following treatment with Herceptin and other oncology therapies. The results found that the median time to disease progression was 8.4 months for patients receiving Tykerb and Xeloda, compared to 4.4 months for patients taking Xeloda alone.

Nomura Code analyst Mike Ward remarked that "a few people have been sceptical about Tykerb because they saw a limited market, but oncologists will vote with their prescribing pen when they see good data." The analyst believes the drug could eventually garner approval for early stages of breast cancer as well. Meanwhile, Morgan Stanley analysts forecasted that Tykerb could garner annual sales of over 1 billion pounds ($1.87 billion) by 2012.

The drugmaker filed Tykerb with the FDA on September 18, and Glaxo said it intends to complete regulatory filings of Tykerb in several countries including Canada and Australia by the end of this year. The drug is also being studied as a treatment for brain metastasis, as well as renal, and head and neck cancer.

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