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Rival Opdivo rejected, Novartis combo gets NICE green light in adjuvant melanoma

Proactive adjuvant treatment could extend melanoma patient lives


England’s cost effectiveness watchdog NICE has recommended the use of Novartis’ Tafinlar (dabrafenib and Mekinst (trametinib) combination in melanoma.

The decision is a boost for Novartis in the UK, where it is in competition with BMS’ immunotherapy Opdivo in adjuvant melanoma treatment.

Just last week NICE issued draft guidance not recommending Opdivo, saying the clinical and cost effectiveness data was not strong enough.

This is good news for Novartis and its combination, although it doesn’t have a direct overlap with its rival – Tafinlar and Mekinst can only be used in patients with BRAF V600 mutation-positive melanoma.

The new approval is for patients with stage III disease and in the adjuvant setting, and aims to remove any residual cancer left behind after surgery to remove the tumour and associated lymph glands.

Current treatment is routine surveillance, which includes regular check-ups and surveillance imaging – it is hoped this more proactive approach to the disease will help extend overall survival in patients.

Clinical trial results showed that patients taking dabrafenib plus 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).

BMS still has a chance to strike a deal in order to gain NICE recommendation, but Novartis will now have a head start. Novartis' recommendation was only possible thanks to price and access negotiations between it, NICE and NHS England.

Mirella Marlow, deputy director for the NICE Centre for Health Technology Evaluation, said: “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.

“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.”

Novartis estimates that 427 people will be eligible for the treatment.

Both drugs are taken orally, dabrafenib twice daily and trametinib once daily. The treatment will be available at a confidential discounted price agreed between NHS England and the company.

BMS has had mixed success in gaining NICE approval for Opdivo across its many cancer indications. A year ago Opdivo gained NICE approval for second line use in the biggest single cancer patient group, non-small cell lung cancer (NSCLC), but its main immunotherapy rival, MSD’s Keytruda has streaked ahead with approval in front line use.

Article by
Andrew McConaghie

18th September 2018

From: Marketing



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