Managed Care

EU watchdog backs Glaxo breast cancer pill

Last Updated: 2007-12-14 16:00:35 -0400 (Reuters Health)

By Ben Hirschler

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 tumours 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.

Dinesh Purandare, vice president for oncology in Europe, said Glaxo expected to make the medicine commercially available in Europe by the end of February or early March, with the first launches set to be in Britain and Germany.

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.

Unlike Herceptin, which aims to block cancer from outside the cell, Tykerb works within cells by blocking two enzymes thought to promote cancer.

It is the first of several cancer drugs that Glaxo hopes to have approved by 2010. Studies of the product are also underway to treat early-stage and inflammatory breast cancers, as well as head and neck, gastric and lung cancers.

(Reporting by Ben Hirschler, editing by Will Waterman)