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