On 25 July 2024, the 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 product Mektovi. The marketing authorisation holder for this medicinal product is Pierre Fabre Medicament.
The CHMP adopted a new indication as follows:
Non-small cell lung cancer (NSCLC)
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
For information, the full indications for Mektovi will be as follows:1
Melanoma
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Non-small cell lung cancer (NSCLC)
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) and made available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1 New text in bold, removed text as strikethrough
CHMP post-authorisation summary of positive opinion for Mektovi (WS-2538)
English (EN) (134.23 KB - PDF)