Encorafenib

Encorafenib (Braftovi, Pierre Fabre Medicament) has 4 EU-approved indications in 3 tumour types. Each needs a biomarker result: BRAF (4).
Approved indications of Encorafenib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer1
BRAF V600E
+ binimetinib
Any line
advanced
None
Colorectal cancer2
BRAF V600E
+ cetuximab and FOLFOX
1L
metastatic
None
BRAF V600E
+ cetuximab
2L
metastatic
After prior systemic therapy
Melanoma1
BRAF V600
+ binimetinib
Any line
advanced
None
Full text of section 4.1 (therapeutic indications)

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 (CRC) • 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. • Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation. Non-small cell lung cancer (NSCLC) Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation. For biomarker-based patient selection, see section 4.2

Label history

17 changes to the Braftovi label since 2019, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes