Posted by Michael Wonder on 21 Sep 2018
Pierre Fabre receives EU approval for Braftovi (encorafenib) + Mektovi (binimetinib) in adult patients with advanced BRAF-mutant melanoma
20 September 2018 - EU approval is based on Phase 3 COLUMBUS trial that demonstrated 14.9 months median progression-free survival and 33.6 months median overall survival versus vemurafenib monotherapy with 7.3 and 16.9 months, respectively.
Pierre Fabre today announced that the European Commission has granted marketing authorisation for the combination of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation, as detected by a validated test.
The EC decision is applicable to all 28 European Union member states plus Liechtenstein, Iceland and Norway.
