Sacituzumab Govitecan: First Approval
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ADISINSIGHT REPORT
Sacituzumab Govitecan: First Approval Yahiya Y. Syed1
© Springer Nature Switzerland AG 2020
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.
Sacituzumab govitecan (Trodelvy™): Key points An antibody-drug conjugate is being developed by Immunomedics for the treatment of solid tumours Received its first approval on 22 April 2020 in the USA Approved for use in adult patients with mTNBC who have received at least two prior therapies for metastatic disease
1 Introduction Sacituzumab govitecan (sacituzumab govitecan-hziy; Trodelvy™) is an antibody–drug conjugate developed by Immunomedics for the treatment of solid tumours, including breast and urothelial cancers [1]. Sacituzumab govitecan was developed by site-specific conjugation of the irinotecan Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.12382289. This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through preclinical and clinical studies to market launch and beyond. * Yahiya Y. Syed [email protected] 1
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand
active metabolite, SN-38 (govitecan), to a humanized monoclonal antibody (hRS7) against trophoblastic cell-surface antigen-2 (Trop-2); SN-38 is covalently linked to hRS7 via a hydrolysable CL2A linker [2–5]. Trop-2 is overexpressed in many solid tumours [3, 4] and has limited expression in normal tissues [6]. Trop-2 plays a role in oncogenesis and is associated with poor prognosis of several cancers, including breast cancer [7]. SN-38 is a moderately-toxic topoisomerase I inhibitor and therefore is conjugated to hRS7 at a high mean drug-to-antibody ratio (7.6) [3]. Use of a less toxic drug may improve therapeutic index of the formulation. Intravenous sacituzumab govitecan received accelerated approval in the USA on 22 April 2020 for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease [8, 9]. The approval was based on results of a phase I/ II trial (NCT01631552); continued approval will requ
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