ENHERTU (AstraZeneca Pty Ltd)
Product name
ENHERTU
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
190 (255 working days)
Active ingredients
trastuzumab deruxtecan
Registration type
NCE/NBE
Indication
Disease and Setting
ENHERTU (powder for injection) is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.
This indication is approved via the provisional approval pathway, based on overall response rate and duration of response. Full registration for this indication depends on verification and description of clinical benefit in a confirmatory trial.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration