Novartis has announced the first BRAF-targeted treatment for post-surgery stage III melanoma patients, the most aggressive type of skin cancer, is to be made available for NHS patients in England and Wales following appraisal by NICE (National Institute for Health and Care Excellence).
Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) has been recommended as a cost-effective treatment option for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following surgery.
Based on the clinical trial results, which showed the drug combination reduced risk of melanoma returning or death by over 50%, the NICE approval comes just days after the European Medicines Agency (EMA) granted approval of the drug’s use in the EU.
The rapid decision is testament to the cost-effectiveness of the treatment. Over 500 people in the UK are diagnosed with BRAF-mutated stage III melanoma each year. Stage III melanoma means that cancer cells have spread into skin, lymph vessels or lymph glands close to the melanoma but they haven’t spread to more distant parts of the body.
Until now, there were no reimbursed drug treatments that offered clear benefits for these patients following surgery. As a result, nearly half (44%) of those with BRAF V600 mutated melanoma suffer a recurrence within a year after surgery, with the risk that the cancer progresses to an incurable state.
Dabrafenib + trametinib will be routinely available on the NHS with immediate effect. The combination treatment is a convenient oral therapy that can be taken at home, consisting of five tablets a day (two dabrafenib twice daily and one trametinib once daily).
Prior to now, post-surgery radiotherapy was the only NICE reimbursed treatment option and it was only used in specific cases. As a result, for the majority of post-surgery patients in the UK, a ‘watch and wait’ approach, to see if the cancer progresses to the next stage was the accepted standard of care.
Dabrafenib + trametinib combination is the first targeted treatment approved in a class of drug known as tyrosine kinase inhibitors (TKIs) to be given following surgery to reduce the risk of melanoma returning. This class of drug blocks molecules within the cells specific to the cancer to slow or stop tumour growth, and have been demonstrated to improve the outcomes of cancer patients.
The NICE recommendation is based on the findings from the pivotal phase III trial, COMBI-AD, which was the first study to demonstrate a clinical benefit in post-surgery patients receiving a targeted therapy combination for a BRAF V600 mutation. The study showed dabrafenib + trametinib significantly reduced the risk of disease recurrence or death by 53% compared to placebo after three years. Well over half of patients (58%) treated with the drug combination had no evidence of recurrence three years after their surgery compared to 39% of those who received placebo.
Gill Nuttall, CEO of Melanoma UK, said: “Worryingly, we are continuing to see an increase in the number of people in the UK with melanoma, especially among younger people. The availability of this treatment is a huge step forward for the hundreds of BRAF-positive patients who are currently left with very few options following surgery. The current ‘watch and wait’ approach is an extremely worrying and stressful time for patients and their families.”
Professor Ruth Plummer, Clinical Professor of Experimental Cancer Medicine, University of Newcastle Upon Tyne said, “This is really significant for these patients and the melanoma community in England and Wales, as the treatment has the potential to transform the standard of care for people with BRAF-positive stage III melanoma. We know this can be a stressful and unsettling as over half of all patients with stage III disease will experience a recurrence in the future, leaving people anxious and worried that their disease might return.”
Mari Scheiffele, Novartis Oncology General Manager, UK & Ireland said, ” We have worked closely with NICE and NHS England to ensure eligible patients in England and Wales have access to this important treatment option at the earliest opportunity.”