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Roche's skin cancer drug Zelboraf recommended in EU

CHMP gives positive opinion for drug's use in advanced melanoma

European regulatory advisors have recommended Roche's Zelboraf be approved to treat an advanced form of skin cancer.

The Committee for Medicinal Products for Human Use (CHMP) backed the drug's use as a monotherapy for adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Zelboraf, which Roche co-developed with Daiichi-Sankyo, could improve overall survival in melanoma patients with tumours that are positive for the BRAF V600 mutation, which can lead to increased and uncontrolled cell growth.

Metastatic melanoma is one of the most aggressive forms of skin cancer, with a mortality rate of over 75 per cent during the first year after diagnosis.

There are around 132,000 new melanoma cases a year and it is thought that mutated forms of the BRAF protein are present in half these.

A protein kinase inhibitor, Zelboraf works by inhibiting the mutated enzyme and is taken as a twice-daily pill. It is designed to be used with a diagnostic test developed by Roche to detect the BRAF mutation.

Zelboraf was approved by Food and Drug Administration in August, 2011 in the US, where Roche said the price of the drug would come to around $56,000 for a six-month course of treatment, but no European price details have been announced.

Roche has a number of other marketing applications for Zelboraf under review in countries that include Australia, New Zealand, Brazil, India, Mexico and Canada.

The final European Commission decision on the marketing authorisation of Zelboraf is expected in February 2012.

19th December 2011

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