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Trodelvy
Published
Product name
Trodelvy
Active ingredient
Sacituzumab govitecan
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Trodelvy (sacituzumab govitecan) was approved for the following therapeutic use:
Trodelvy 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.
How this medicine works
Sacituzumab govitecan is a trophoblast cell surface antigen 2 (Trop-2)-directed antibody-drug conjugate. Sacituzumab is a humanised antibody that recognises Trop-2. The small molecule, SN-38, is a topoisomerase I inhibitor, which is covalently attached to the antibody by a linker. Pharmacology data suggest that sacituzumab govitecan binds to Trop-2-expressing cancer cells and is internalised with the subsequent release of SN-38 via hydrolysis of the linker. SN-38 interacts with topoisomerase I and prevents re-ligation of topoisomerase I-induced single strand breaks. The resulting DNA damage leads to apoptosis and cell death. Sacituzumab govitecan decreased tumour growth in mouse xenograft models of triple-negative breast cancer.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Trodelvy was considered favourable for the therapeutic use approved.
Sponsor