We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
TRODELVY (Gilead Sciences Pty Ltd)
Product name
TRODELVY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
108 (255 working days)
Active ingredients
sacituzumab govitecan
Registration type
EOI
Indication
HR+/HER2- metastatic breast cancer
TRODELVY is indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy (including a CDK4/6 inhibitor) and at least two additional systemic therapies in the locally advanced or metastatic setting.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available