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TRODELVY (Gilead Sciences Pty Ltd)

Product name
TRODELVY
Date registered
Evaluation commenced
Decision date
Approval time
111 (255 working days)
Active ingredients
sacituzumab govitecan
Registration type
NCE/NBE
Indication

TRODELVY (powder for injection) is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies, including at least one prior therapy for locally advanced or metastatic disease.

Registration process

Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available

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