Binimetinib

Binimetinib (Mektovi, Pierre Fabre Medicament) has 2 EU-approved indications in 2 tumour types. Each needs a biomarker result: BRAF (2).
Approved indications of Binimetinib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer1
BRAF V600E
+ encorafenib
Any line
advanced
None
Melanoma1
BRAF V600
+ encorafenib
Any line
advanced
None
Full text of section 4.1 (therapeutic indications)

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 non-small cell lung cancer with a BRAF V600E mutation.

Label history

12 changes to the Mektovi label since 2019, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes