On 25 July 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal products encorafenib (Braftovi) and binimetinib (Mektovi).
The marketing authorisation holder for these medicinal products is Pierre Fabre Medicament.
The CHMP adopted new indications as follows:
Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.
and
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced NSCLC with a BRAF V600E mutation.
For information, the full indications for Braftovi will be as follows (new indication in bold):
Melanoma
Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Colorectal cancer
Encorafenib in combination with cetuximab, is indicated for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, who have received prior systemic therapy.
Non-small cell lung cancer (NSCLC)
Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced NSCLC with a BRAF V600E mutation.
For information, the full indications for binimetinib will be as follows (new indication in bold):
Melanoma
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Non-small cell lung cancer (NSCLC)
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced NSCLC with a BRAF V600E mutation.
Detailed recommendations for the use of these products will be described in the updated summaries of product characteristics, which will be published in the revised European public assessment reports and made available in all official European Union languages after a decision on these changes to the marketing authorisations has 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 opinion.