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EC grants Tyverb approval

The European Commission granted GlaxoSmithKline conditional marketing authorisation for its breast cancer treatment, Tyverb, in June.
The European Commission (EC) granted GlaxoSmithKline(GSK) conditional marketing authorisation for its breast cancer treatment, Tyverb, in June.

Tyverb is now indicated for use in all 27 EU member states for the treatment of patients with HER2-positive breast cancer with progressive disease following prior therapy.

"Today's news will benefit women across Europe with HER2-positive advanced or metastatic breast cancer, which needs further treatment after the previous standard treatments," said Professor David Cameron, co-principle investigator of the phase III trial, director of National Cancer Research Network and chair of medical oncology, faculty of medicine and health at the University of Leeds.

GSK is now working with individual European markets to make the drug available as soon as possible. The company says the drug has a novel mechanism of action and works by getting inside the cancer cell and inhibiting the tyrosine kinase components of the erb1 and erb2 receptors.

Conditional authorisation means, however, that the company will be required to provide further data on Tyverb's performance and that the licence is only valid for one year, although it can be renewed. The EC recognises that the requirement for a drug to tackle this unmet medical need outweighs the inherent risks of not being in possession of completed pivotal study data.

He explained that the drug, developed to be administered as on oral dose rather than intravenously, "will play a valuable role in treating this especially aggressive form of advanced breast cancer."

GSK revealed that a comprehensive clinical development programme for the drug is currently underway to assess it in combination with treatments such as chemotherapy and hormonal therapy.

Trials are also being conducted into the medication's efficacy in other tumours including gastric, head and neck cancer.

In April, the company presented data about Tyverb to the 6th European Breast Cancer Conference, showing that it decreased tumourigenic stem cells in the more aggressive forms of breast cancer. Studies showed that it caused significant regression of primary tumours.

The CHMP gave the drug a positive opinion in April 2008.

12th June 2008

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