KIMMTRAK (Adjutor Healthcare Pty Ltd)
Product name
KIMMTRAK
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
120 (255 working days)
Active ingredients
tebentafusp
Registration type
NCE/NBE
Indication
KIMMTRAK (concentrated solution for infusion) is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.