BRAFTOVI (Pierre Fabre Australia Pty Ltd)
Product name
BRAFTOVI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
198 working days (255)
Active ingredients
encorafenib
Registration type
NCE/NBE
Indication
BRAFTOVI in combination with MEKTOVI (binimetinib) is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by a validated test.