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Roche wins conditional EU approval for cancer drug Erivedge

Can market it for advanced basal cell carcinoma but must provide more safety data

Roche Basel Switzerland

Roche's new oncology drug Erivedge has won EU approval to treat patents with the skin cancer advanced basal cell carcinoma (BCC).

The approval, granted by the European Commission (EC), is conditional, meaning that Roche is required to provide additional safety data from an ongoing study on the use of Erivedge (vismodegib) in the cancer.

This form of approval is reserved for medicines that satisfy an unmet medical need and whose availability would result in a significant public health benefit, as is the case for BCC, which is the most common type of skin cancer in Europe but has few treatment options for the advanced form of the disease.

Other drugs to receive conditional approval in Europe in recent years include GlaxoSmithKline's (GSK) renal cell carcinoma treatment Votrient (pazopanib), Pfizer's chronic myelogenous leukaemia (CML) treatment Bosulif (bosutinib) and Cell Therapeutics' Pixuvri (pixantrone) for non-Hodgkin B-cell lymphoma.

GSK last week received news that the European Medicines Agency (EMA) had agreed to remove the conditional tag and grant full marketing authorisation to Votrient, and Roche will be able to request similar status if the safety data for Erivedge in BCC proves to be positive.

The drug has already demonstrated its effectiveness, with the EMA's Committee for Medicinal Products for Human Use (CHMP) recommending Erivedge in April this year based on trials showing it could reduce the size of lesions on the skin in 43 per cent of patients with locally advanced BCC and 30 per cent of patients with metastatic BCC.

Roche's chief medical officer and head of global development Hal Barron said the approval of Erivedge was "great news for patients with advanced basal cell carcinoma".

Erivedge is already available in the US, where it was approved by the Food and Drug Administration (FDA) in January 2012, several months ahead of the FDA's review deadline and the drug has also been approved in Switzerland, Australia, Israel, South Korea, Mexico and Ecuador.

15th July 2013

From: Sales

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