Posted by Michael Wonder on 29 Jul 2018
Braftovi (encorafenib) + Mektovi (binimetinib) receives positive CHMP opinion for advanced BRAF mutant melanoma
27 July 2018 - Positive CHMP opinion is based on Phase 3 COLUMBUS trial which demonstrated nearly 15 months median progression-free survival and over 30 months median overall survival.
Array BioPharma today announced that the CHMP of the EMA adopted a positive opinion recommending approval of Braftovi in combination with Mektovi for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation.
The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The final EC decision, expected by the end of September, will be applicable to all 28 EU member states, as well as Liechtenstein, Iceland and Norway.
