NICE has recommended Zelboraf (vemurafenib) for the treatment of BRAF mutation positive unresectable or metastatic melanoma, noting it to be a “step-change” in the treatment of the disease. In accordance with its licence, the treatment will now also be available to patients as a first and second line therapy. Vemurafenib, an oral therapy that targets the activity of the faulty BRAF V600 gene present in half of patients with inoperable metastatic melanoma, is the only medicine in its class shown to improve survival rates and stall the growth or spread of cancer. Clinical trials have shown a 40% improvement in median overall survival (median 13.6 months compared to 9.7 months with dacarbazine); an increase in median progression free survival of over four months survival (median 6.9 months compared to 1.6 months with dacarbazine) and an overall response rate of 57%, compared to 8.6% with standard chemotherapy (dacarbazine). Dr James Larkin who led the clinical trial at The Royal Marsden said: “The results of this trial represents the biggest breakthrough in the treatment of melanoma for more than 30 years. We are already seeing the positive impact this drug is having on our patients and clinical trials have shown a very significant prolongation of life in comparison with chemotherapy.”