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NICE recommends Novartis combo as first-ever BRAF-targeted therapy for advanced post-surgery melanoma

Published on 17/09/18 at 10:25am

NICE has taken the decision to recommend the first ever first BRAF-targeted therapy for use on the NHS in England and Wales for post-surgery stage III melanoma with a BRAF V600 mutation: the combination of Novartis’ Tafinlar (dabrafenib) and Mekinist (trametinib).

The five-pill-a-day treatment was deemed to be cost-effective based on data which showed that it reduced the risk of disease returning or death by 53%. Additionally, around 58% of patients treated with the combination showed no evidence or recurrence three years after their surgery compared to 39% of placebo patients.  

“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,” said Professor Ruth Plummer, Clinical Professor of Experimental Cancer Medicine, University of Newcastle Upon Tyne. “Previously, there were limited treatment options available to patients who had undergone surgery, and the majority would simply have to hope their melanoma would not return.

“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. It is clear that treating patients with dabrafenib and trametinib after their surgery reduces the chance of recurrence”

The combination was approved by the EMA just days before; there are around 500 patients eligible for the therapy that are newly diagnosed each year. Until now, there have been no available treatments which offer clear benefits to patients following surgery, with around 44% of BRAF V600-mutated patients seeing their disease return within a year. Melanoma causes more deaths in the UK than all other skin cancers combined.

“The approval of dabrafenib in combination with trametinib will offer marked benefits to many people living with stage III BRAF-positive melanoma in the UK, following surgery,” commented Mari Scheiffele, Novartis Oncology General Manager, UK & Ireland. “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.”

Matt Fellows

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