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NICE publish appraisal for encorafenib (Braftovi▼) in treating melanoma

Braftovi▼, for Melanoma from Pierre Fabre

The National Institute for Health and Care Excellence (NICE) has recommended that Pierre Fabre's melanoma treatment encorafenib, brand name Braftovi▼, in combination with another medicine binimetinib, as an option for treating for unresectable or metastatic BRAF V600 mutation-positive melanoma.

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Why the committee made these recommendations
Current treatments for unresectable or metastatic BRAF V600 mutation-positive melanoma include targeted therapy, usually using a combination of a BRAF and MEK inhibitor (dabrafenib with trametinib) or sometimes monotherapy with a BRAF inhibitor (vemurafenib or dabrafenib).

Clinical trial evidence shows that, compared with vemurafenib, encorafenib with binimetinib extends the time until melanoma progresses and also how long people live. There are no trials directly comparing it against dabrafenib with trametinib. But compared indirectly, encorafenib with binimetinib appears to be as effective as dabrafenib with trametinib.

When the commercial arrangements for encorafenib, binimetinib, dabrafenib and trametinib are taken into account, encorafenib with binimetinib is considered to be a cost-effective use of NHS resources. It is therefore recommended.

About Braftovi (source EMA)
Braftovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.

Braftovi is used in combination with another medicine, binimetinib (Mektovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.

In melanoma tumours with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division. This encourages cancers to develop by allowing uncontrolled division of cells. The active substance in Braftovi, encorafenib, works by blocking the BRAF protein thereby stopping its activation by MEK and slowing down the growth and spread of the cancer.

Braftovi was first made available in the EU in 2018. It is manufactured by Pierre Fabre.

European Medicines Agency website page for Braftovi
Accessed 01/05/19
Links and citations available in full article

© NICE [2019]

Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma [TA562]
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

The information provided by NICE was accurate at the time this article was issued.

NICE guidance: Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma

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