ENHERTU (AstraZeneca Pty Ltd)
Product name
ENHERTU
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
195 (255 working days)
Active ingredients
trastuzumab deruxtecan
Registration type
EOI
Indication
HER2-low and HER2-ultralow
ENHERTU as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HR+ and either HER2-low (IHC 1+ or IHC 2+/ISHnegative) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.