Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
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.