From: Reuters
Published December 14, 2007 06:32 AM

EU watchdog backs Glaxo breast cancer pill

LONDON (Reuters) - The European Medicines Agency has recommended conditional approval of GlaxoSmithKline Plc's new breast cancer pill Tykerb, Europe's biggest drugmaker said on Friday.

The medicine, which is already on sale in the United States, will be marketed as Tyverb in Europe. It is designed to be given in combination with Roche Holding AG's Xeloda for treating patients with advanced or metastatic breast cancer whose tumors overexpress the HER2 protein.

The news is a boost for Glaxo, which is aiming to increase its position in the fast-growing cancer market.

The conditional approval -- if endorsed by the European Commission within a couple of months, as expected -- means the drug can sold immediately but that additional clinical data are still required.


Glaxo said it would provide further data from a pivotal study of the medicine and also an additional demonstration of decreased incidence of relapse in the central nervous system, for which a study will be conducted.

Because Tykerb, known generically as lapatinib, is given as a pill it is more convenient than Roche and Genentech Inc's blockbuster Herceptin, which works in a similar way but must be injected.

(Reporting by Ben Hirschler; Editing by Paul Bolding)

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