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Roche's melanoma drug Zelboraf cleared in EU

Region’s first personalised medicine for the skin cancer melanoma could make $1bn-$1.5bn per year at peak

Roche has said its Zelboraf drug has become the first personalised medicine for the skin cancer melanoma to be approved by the European Commission (EC).

Zelboraf (vemurafenib) has been given marketing authorisation as a single-agent therapy for adult patients with unresectable or metastatic melanoma who test positive for the BRAF V600 genetic mutation, the most aggressive form of skin cancer.

The mutated form of the BRAF protein occurs in about half of all melanoma cases and is detected by a polymerase chain reaction (PCR)-based diagnostic test.

Roche says that Zelboraf is the first targeted treatment that has been shown to extend survival in melanoma patients and improve their quality of life.

Data from the late-stage BRIM3 trial showed that the risk of death was reduced by 63 per cent for patients on Zelboraf compared to those who received standard first-line melanoma treatment.

In addition, Roche's drug significantly improved survival by more than three months, at 13.2 months versus 9.6 months for chemotherapy.

Roche won approval in the US for Zelboraf for a similar indication in August 2011, marking the first time that the company had simultaneously launched a new therapeutic and a companion diagnostic, and Roche said in its annual results statement that initial sales had been "very encouraging".

In the US, Zelboraf is co-marketed by Roche subsidiary Genentech and Daiichi Sankyo, which owns Plexikkon, the company that originally discovered Zelboraf.  Roche said it booked $30m in its first few weeks on the US market.

The drug has also been registered in Switzerland, Brazil, Israel, Canada and New Zealand, with Swiss sales contributing another $1m in 2011.

Analysts have predicted that annual Zelboraf sales will reach $1bn-$1.5bn at peak.

Meanwhile, Roche is also looking at new combinations with the drug. In December 2011, in collaboration with Bristol Myers Squibb, the company initiated a phase I/II study of Zelboraf and BMS' Yervoy (ipilimumab) in BRAF-mutated metastatic melanoma.

In a statement, Roche's chief medical officer Hal Barron said that Zelboraf "exemplifies the benefits that Roche’s personalised approach to medicine can provide for patients, physicians and society".

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