Difference between revisions of "Sacituzumab govitecan (Trodelvy)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *4/22/2020: Granted accelerated approval for adult patients with metastatic triple-negative [[breast cancer]] who received | + | *4/22/2020: Granted accelerated approval for adult patients with metastatic [[Breast cancer, triple negative|triple-negative breast cancer]] who received at least two prior therapies for metastatic disease. |
| + | *4/7/2021: Granted regular approval for patients with unresectable locally advanced or metastatic [[Breast cancer, triple negative|triple-negative breast cancer]] (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. | ||
==Also known as== | ==Also known as== | ||
Revision as of 22:17, 7 April 2021
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 used
History of changes in FDA indication
- 4/22/2020: Granted accelerated approval for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease.
- 4/7/2021: 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.
Also known as
- Code names: IMMU-132, RS7-SN38
- Generic name: sacituzumab govitecan-hziy
- Brand name: Trodelvy