Basic Information
Braftovi
Regulatory Information
EMEA/H/C/004580
September 19, 2018
July 26, 2018
15
December 10, 2024
Company Information
France
Les Cauquillous 81500 - Lavaur
PIERRE FABRE MEDICAMENT
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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 (CRC) 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 non-small cell lung cancer with a BRAF V600E mutation.
Overview Summary
Braftovi is a medicine used in adults for treating certain cancers when their cells have a mutation (change) in their genes called 'BRAF V600'. Braftovi is used in combination with another medicine, binimetinib to treat: - melanoma (a skin cancer) that cannot be removed by surgery or has spread; - a type of lung cancer called non-small cell lung cancer (NSCLC). It is used when the cancer is advanced and has the BRAF V600E version of the mutation. Braftovi is also used in combination with the medicine cetuximab to treat colorectal cancer (cancer of the large bowel or rectum) with the BRAF V600E version of the mutation, when it has spread elsewhere in the body and has previously been treated with other systemic (given by mouth or injection) medicines. Braftovi contains the active substance encorafenib.