posted on 2020-06-12, 04:38authored byYahiya Y. Syed
Compliance with Ethical Standards
Disclosure: The preparation of this review was not supported by any external funding.
Conflict of interest:
During the peer review process the manufacturer of the agent under
review was offered an opportunity to comment on the article. Changes
resulting from any comments received were made by the authors on the
basis of scientific completeness and accuracy. Yahiya Y. Syed is a
salaried employee of Adis International Ltd/Springer Nature, is
responsible for the article content and declares no relevant conflicts
of interest.
Additional
information about this Adis Drug Review can be found here
Abstract
Sacituzumab govitecan (sacituzumab govitecan-hziy; Trodelvy™) is a Trop-2-directed antibody conjugated to a topoisomerase I inhibitor (SN-38) that is being developed by Immunomedics for the treatment of solid tumours, including breast cancer. In April 2020, sacituzumab govitecan received accelerated approval in the USA for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Sacituzumab govitecan is undergoing phase III development for breast cancer in the USA and EU, and phase II development for urothelial cancer. It is also being explored for brain metastases, glioblastoma, endometrial cancer and prostate cancer. This article summarizes the milestones in the development of sacituzumab govitecan leading to this first approval for mTNBC.