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Votrient receives conditional EU authorisation

GlaxoSmithKline's renal cell cancer drug, Votrient, has received conditional marketing authorisation in the EU

GlaxoSmithKline (GSK) has announced that its renal cell cancer drug, Votrient (pazopanib) has been granted conditional marketing authorisation by the European Commission.

As part of these conditions, GSK will provide data from ongoing clinical studies before full authorisation is granted.

Votrient is intended for use in the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.

The drug was previously recommended by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in April 2010.

The committee found a “favourable benefit to risk balance” with the drug, though proposed it should only be initiated by a physician experienced in the administration of anti-cancer agents.

The positive recommendation was a revision of an earlier negative one. The decision to change the recommendation followed the removal of Votrient from the EMA's community register of orphan medicinal products by GSK.

A drug can only be on the register if is intended for the diagnosis, prevention or treatment of a condition affecting fewer than five per ten thousand persons in the EU or if it will carry a notable benefit for the treatment a serious or debilitating disease and is unlikely to be marketed without incentives.

Votrient was previously approved in the US by the Food and Drug Administration (FDA) in October 2009 as a treatment for patients with advanced RCC.

15th June 2010

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