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Roche launches targeted skin cancer drug Zelboraf in the UK

The potential blockbuster will be made available along with a companion biomarker test

Roche has launched its targeted skin cancer drug Zelboraf (vemurafenib) in the UK along with a companion biomarker test to identify patients who could benefit from the advanced melanoma treatment.

The potential blockbuster is the first personalised medicine for the disease to be approved in Europe.

Zelboraf was licensed last month by the European Commission for use as single-agent therapy in adult patients with unresectable or metastatic melanoma who test positive for the BRAF V600 genetic mutation, the most aggressive form of skin cancer.

In clinical trials led in the UK by the Royal Marsden Hospital, patients treated with Zelboraf lived an average of 13.2 months longer compared with 9.6 months for patients who received standard chemotherapy.

These patients, who had BRAF-mutant advanced cancers, were almost nine times more likely to respond to Zelboraf than to standard chemotherapy (48.4 per cent versus 5.5 per cent).

The mutated BRAF gene drives cancer development in around 50 per cent of malignant melanomas, according to research by the Institute of Cancer Research (ICR).

Its CEO Professor Alan Ashworth said: “Advanced melanoma is a devastating disease and new treatments are desperately needed, so it's especially pleasing that patients will now be able to benefit from a drug that we helped develop.

“The success of vemurafenib demonstrates the importance of our approach to developing personalised medicines for cancer. Understanding the genetic and molecular causes of cancer helps us to create new, targeted therapies that - as this drug shows - can prove extremely effective.”

Zelboraf, which is taken as four pills twice a day, has been designed to block this cancer-causing form of the BRAF gene.

Roche won US approval 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".

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

Zelboraf and Bristol-Myers Squibbb's (BMS) antibody treatment Yervoy (ipilimumab), which was launched last year, represent the first major advances in treatment for 30 years for patients with advanced melanoma.

Uptake of both drugs in the UK will be governed by the judgement of the country's National Institute for Health and Clinical Excellence (NICE), which is currently appraising Zelboraf and Yervoy, and in October 2011 issued negative draft guidance on BMS' drug.

The watchdog said Yervoy, which costs around £80,000 per patient, was not a cost-effective option based on available data, and highlighted the drug's lack of personalisation.

In January, NICE suspended Yervoy's appraisal to allow BMS to submit a Department of Health-approved patient access scheme that the manufacturer hopes will provide new evidence of the drug's cost-effectiveness.

Meanwhile, Zelboraf's appraisal remains on-going and NICE expects to issue guidance on the drug's use to treat unresectable locally advanced or metastatic BRAF V600 mutation positive malignant melanoma in October.

14th March 2012


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