CHMP recommends Braftovi + cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation.- Pierre Fabre

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 Braftovi. The marketing authorisation holder for this medicinal product is Pierre Fabre Medicament.

The CHMP adopted a new indication as follows: The CHMP adopted a new indication as follows : Encorafenib is indicated: in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.In combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.