NICE nod for Novartis’ targeted skin cancer combo

Final draft guidelines are recommending the combination for use in patients with stage III BRAF V600 mutation-positive melanoma who have disease that has spread to lymph vessels, or lymph glands close to the melanoma and who have already had surgery to remove the tumour and associated lymph glands.

To date, this patient group had almost no other treatment options following surgery, aside from radiotherapy in some circumstances, but in over half of cases the cancer recurs, increasing the risk of progressing to the most advanced and incurable stage of the disease.

The aim of Novartis’ adjuvant therapy is to remove any residual cancer left behind to prevent recurrence, and clinical trial results show that patients taking Tafinlar (dabrafenib) plus Mekinst (trametinib) had higher rates of relapse-free survival (88% at 1 year, 67% at 2 years, and 58% at 3 years) compared with patients taking the placebo (56% at 1 year, 44% at 2 years, and 39% at 3 years).

"There are currently no adjuvant treatments available for people with stage III BRAF V600 mutation-positive melanoma, a disease which can cause severe and debilitating symptoms," said Mirella Marlow, deputy director for the NICE Centre for Health Technology Evaluation.

"We are therefore delighted that we were able to work with the company and NHS England to recommend dabrafenib plus trametinib as a new treatment option, marking an important development in the management of melanoma."

"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," added Gill Nuttall, chief executive of Melanoma UK.

Novartis estimates that around 427 people will be eligible for this treatment, which was recently approved in both the US and EU.

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