MEKTOVI (Pierre Fabre Australia Pty Ltd)
Product name
MEKTOVI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
114 (175 working days)
Active ingredients
binimetinib
Registration type
EOI
Indication
Melanoma
Binimetinib in combination with encorafenib 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.
Non-small cell lung cancer (NSCLC)
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer with a BRAF V600E mutation.