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ENHERTU (AstraZeneca Pty Ltd)
Product name
ENHERTU
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
97 (255 working days)
Active ingredients
trastuzumab deruxtecan
Registration type
EOI
Indication
Metastatic Breast Cancer
HER2-Low
ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Patients with hormone receptor positive (HR+) breast cancer should additionally have received and no longer be considered eligible for endocrine therapy.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available