Difference between revisions of "Sacituzumab govitecan (Trodelvy)"
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*[[Breast cancer, ER-positive|HR+ breast cancer]] | *[[Breast cancer, ER-positive|HR+ breast cancer]] | ||
*[[Breast_cancer,_triple_negative|TNBC]] | *[[Breast_cancer,_triple_negative|TNBC]] | ||
| − | + | *[[Urothelial carcinoma]] | |
| − | *[[ | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
===[[Breast cancer]]=== | ===[[Breast cancer]]=== | ||
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**2021-04-07: Granted regular approval for patients with unresectable locally advanced or metastatic triple-negative [[breast cancer]] (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. ''(Based on ASCENT)'' | **2021-04-07: Granted regular approval for patients with unresectable locally advanced or metastatic triple-negative [[breast cancer]] (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. ''(Based on ASCENT)'' | ||
*2023-02-03: Approved for 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 and at least two additional systemic therapies in the metastatic setting. ''(Based on TROPiCS-02)'' | *2023-02-03: Approved for 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 and at least two additional systemic therapies in the metastatic setting. ''(Based on TROPiCS-02)'' | ||
| − | ===[[ | + | ===[[Urothelial carcinoma]]=== |
| − | *2021-04-13: Granted accelerated approval for patients with locally advanced or metastatic [[ | + | *2021-04-13: Granted accelerated approval for patients with locally advanced or metastatic [[Urothelial carcinoma|urothelial cancer]] (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. ''(Based on TROPHY-U-01)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
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[[Category:Topoisomerase inhibitors]] | [[Category:Topoisomerase inhibitors]] | ||
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[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
| + | [[Category:Urothelial carcinoma medications]] | ||
[[Category:EMA approved in 2021]] | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
[[Category:Health Canada approved in 2021]] | [[Category:Health Canada approved in 2021]] | ||
Revision as of 13:21, 9 September 2023
Mechanism of action
From the NCI Drug Dictionary: An antibody-drug conjugate containing the humanized monoclonal antibody, hRS7, against tumor-associated calcium signal transducer 2 (TACSTD2 or TROP2) and linked to the active metabolite of irinotecan, 7-ethyl-10-hydroxycamptothecin (SN-38), with potential antineoplastic activity. The antibody moiety of sacituzumab govitecan selectively binds to TROP2. After internalization and proteolytic cleavage, SN-38 selectively stabilizes topoisomerase I-DNA covalent complexes, resulting in DNA breaks that inhibit DNA replication and trigger apoptosis.
Diseases for which it is established
History of changes in FDA indication
Breast cancer
- 2020-04-22: Granted accelerated approval for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. (Based on IMMU-132-01)
- 2021-04-07: Granted regular approval for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. (Based on ASCENT)
- 2023-02-03: Approved for 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 and at least two additional systemic therapies in the metastatic setting. (Based on TROPiCS-02)
Urothelial carcinoma
- 2021-04-13: Granted accelerated approval for patients with locally advanced or metastatic urothelial cancer (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. (Based on TROPHY-U-01)
History of changes in EMA indication
- 2021-11-22: Initial marketing authorization as Trodelvy.
History of changes in Health Canada indication
- 2021-09-24: Initial notice of compliance for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior therapies, at least one of them for metastatic disease.
Also known as
- Code names: IMMU-132, RS7-SN38
- Generic name: sacituzumab govitecan-hziy
- Brand name: Trodelvy