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March 12, 2012

Zelboraf oral therapy receives approval for UK market

The European Union Commission has licensed the use of Zelboraf (vemurafenib) in the UK to treat patients with BRAF V600 mutation positive unresectable or metastatic melanoma.

The European Commission has licensed the use of Zelboraf (vemurafenib) in the UK to treat patients with BRAF V600 mutation positive unresectable or metastatic melanoma.

Developed at The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Zelboraf is an oral therapy that targets the activity of the faulty BRAF V600 gene in patients with inoperable metastatic melanoma.

During the study period, the estimated risk of death for patients who received vemurafenib reduced by 38%, with a median overall survival time of 13.2 months for patients who received vemurafenib compared to 9.6 months for patients who received standard chemotherapy.

Previous trials showed that vemurafenib demonstrated 48.8% partial and complete response rate compared to 5.5% partial and complete response rate with dacazarbine.

The studies also demonstrated that vemurafenib reported an 8.8 fold improvement in best overall response rate in first line patients.

In August 2011, vemurafenib received US Food and Drug Administration (FDA) approval for the treatment of late-stage melanoma.

The European Commission has recently cleared vemurafenib as a monotherapy for the treatment of adult patients with BRAF V600 mutation positive unresectable or metastatic melanoma.

Currently, a test is available to identify the presence of the BRAF V600 predictive biomarker in patients and their suitability to the treatment.

The test will allow doctors to be precise when making treatment decisions and ensure vemurafenib is prescribed to those who could benefit.

Melanoma is a malignant tumour of melanocytes, the cells that produce the dark pigment, melanin, which is responsible for the colour of skin.

In the UK, the rates of malignant melanoma have risen faster than any other common cancer, with an estimated 2,000 people dying from the disease in the country annually.

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