FULVESTRANT-AFT (AFT Pharmaceuticals Pty Ltd)
Product name
FULVESTRANT-AFT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
146 (255 working days)
Active ingredients
Fulvestrant
Registration type
New generic medicine
Indication
Fulvestrant-AFT is indicated for the treatment of postmenopausal women with:
- Hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer who have not been previously treated with endocrine therapy.
- HR positive, locally advanced or metastatic breast cancer who have progressive disease following prior endocrine (anti-oestrogen or aromatase inhibitor) therapy.