Drug Overview
Nexavar (sorafenib; Bayer/Amgen) is an orally available, multi-targeted tyrosine kinase inhibitor that is directed against several targets, including CRAF, BRAF, RET, KIT, FMS-like tyrosine kinase 3, vascular endothelial growth factor receptor (VEGFR)-2, VEGFR-3, and platelet-derived growth factor receptor. As a result of its multi-targeted nature, it is thought to inhibit both angiogenesis and proliferation of tumor cells.
Nexavar was the first systemic therapy approved for the first-line treatment of advanced hepatocellular carcinoma.
Gaining approval in the US in 2007, Nexavar has been firmly established as the standard of care in this patient group, facing no competition in this setting until the approval of Lenvima (lenvatinib; Eisai/Merck & Co) in 2017 (US). Nexavar is nearing the end of its product lifecycle, with generic competition expected in 2020 (US), 2021 (EU), and 2022 (Japan).
Nexavar (sorafenib; Bayer/Amgen) is an orally available, multi-targeted tyrosine kinase inhibitor that is directed against several targets, including CRAF, BRAF, RET, KIT, FMS-like tyrosine kinase 3, vascular endothelial growth factor receptor (VEGFR)-2, VEGFR-3, and platelet-derived growth factor receptor. As a result of its multi-targeted nature, it is thought to inhibit both angiogenesis and proliferation of tumor cells.
Nexavar was the first systemic therapy approved for the first-line treatment of advanced hepatocellular carcinoma.
Gaining approval in the US in 2007, Nexavar has been firmly established as the standard of care in this patient group, facing no competition in this setting until the approval of Lenvima (lenvatinib; Eisai/Merck & Co) in 2017 (US). Nexavar is nearing the end of its product lifecycle, with generic competition expected in 2020 (US), 2021 (EU), and 2022 (Japan).
Table of Contents
OVERVIEW- Drug Overview
- Product Profiles
- Nexavar : Hepatocellular carcinoma (HCC)
- Nexavar : Renal cell carcinoma (RCC)
LIST OF FIGURES
Figure 1: The author's drug assessment summary of Nexavar for HCC
Figure 2: The author's drug assessment summary of Nexavar for HCC
Figure 3: Nexavar sales for HCC across the US, Japan, and five major EU markets, by country, 2018–27
Figure 4: Nexavar for RCC – SWOT analysis
Figure 5: The author's drug assessment summary of Nexavar for RCC
Figure 6: The author's drug assessment summary of Nexavar for RCC
Figure 7: Nexavar sales for RCC across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
Table 1: Nexavar drug profile
Table 2: Approval history of Nexavar for HCC in the US, Japan, and five major EU markets
Table 3: Late-phase trials of Nexavar for HCC
Table 4: Nexavar for HCC – SWOT analysis
Table 5: Nexavar drug profile
Table 6: Nexavar pivotal trial data in RCC
Table 7: Nexavar Phase III data in RCC
Table 8: Nexavar sales for RCC across the US, Japan, and five major EU markets, by country ($m), 2017–26
