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- Title
Nirogacestat: First Approval.
- Authors
Keam, Susan J.
- Abstract
Nirogacestat (OGSIVEO™) is an oral, selective, reversible, small molecule γ-secretase inhibitor developed by SpringWorks Therapeutics, Inc. γ-Secretase is a multi-subunit protease complex that cleaves multiple transmembrane protein complexes, including Notch and membrane-bound B-cell maturation antigen (BCMA). Inhibition of γ-secretase may result in growth inhibition of tumour cells overexpressing Notch, and preservation of membrane-bound BCMA may increase target density for BCMA-targeted therapy. In November 2023, nirogacestat was approved in the USA for use in adult patients with progressing desmoid tumours who require systemic treatment. This article summarizes the milestones in the development of nirogacestat leading to this first approval for the systemic treatment of desmoid tumours.
- Subjects
UNITED States; PATIENT safety; CONNECTIVE tissue tumors; DRUG approval; PHARMACY information services; PROTEOLYTIC enzymes; DRUG efficacy; DRUG development; PROGRESSION-free survival; MEMBRANE proteins; TUMOR necrosis factors; CELL receptors; CHEMICAL inhibitors
- Publication
Drugs, 2024, Vol 84, Issue 3, p355
- ISSN
0012-6667
- Publication type
Article
- DOI
10.1007/s40265-024-02002-x