EMA Recommends Granting Marketing Authorisations for Encorafenib and Binimetinib

Combination of two medicines is intended in the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation

On 26 July 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorisation for the medicinal products encorafenib (Braftovi) and binimetinib (Mektovi), intended for use in combination for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. 

The applicant for these medicinal products is Pierre Fabre Medicament. 

Braftovi will be available as 50 mg and 75 mg hard capsules. The active substance of Braftovi is encorafenib, an antineoplastic agent that inhibits the activity of the BRAF V600 kinase and subsequently blocks the MAPK pathway. 

Mektovi will be available as a 15 mg film-coated tablets. The active substance of Mektovi is binimetinib, an antineoplastic agent (ATC code: L01XE41) that inhibits the kinase activity of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. 

The benefits with the use of the combination of these two medicinal products are ability to prolong progression-free survival and overall survival in melanoma patients harbouring a BRAF V600 mutation compared to vemurafenib (960mg twice a day). 

The most common side effects of Braftovi are hyperkeratosis, alopecia, palmar-plantar erythrodysaesthesia syndrome, fatigue, rash, arthralgia, dry skin, nausea, myalgia, headache, vomiting and pruritus. 

The most common side effects of Mektovi are fatigue, nausea, diarrhoea, vomiting, retinal detachment, abdominal pain, arthralgia, increased blood creatine kinase and myalgia. 

The full indication for these two medicinal products is: 

  • Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. 
  • Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. 

It is proposed that the combination therapy with these two medicinal products should be initiated and supervised under the responsibility of a physician experienced in the use of anticancer medicinal products. 

Detailed recommendations for the use of these two products will be described in the summary of product characteristics, which will be published in the European public assessment reports and made available in all official European Union languages after the marketing authorisation have been granted by the European Commission. 

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinions.