Notice for trastuzumab deruxtecan (AstraZeneca Pty Ltd)
Active ingredients
trastuzumab deruxtecan
Sponsor
Date of review outcome
Lapse date
Type
Priority review
Indication
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 a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Patients with hormone receptor-positive breast cancer should additionally have received or be ineligible for endocrine therapy.
Therapeutic area
Oncology