ENHERTU (AstraZeneca Pty Ltd)
Product name
ENHERTU
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
112 (255 working days)
Active ingredients
trastuzumab deruxtecan
Registration type
EOI
Indication
ENHERTU as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who previously received:
- trastuzumab and a taxane for metastatic disease, or
- one prior anti-HER2-based regimen and developed disease recurrence during or within six months of completing neo-adjuvant or adjuvant therapy.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available