BRAFTOVI (Pierre Fabre Australia Pty Ltd)
Product name
BRAFTOVI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
148 (255 working days)
Active ingredients
encorafenib
Registration type
EOI
Indication
Colorectal Cancer
BRAFTOVI (hard capsule), in combination with cetuximab, is now also indicated for the treatment of adult patients who have metastatic colorectal cancer (mCRC) with a BRAF V600E mutation as detected by a validated test, and who have received prior systemic therapy.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available