Avastin (bevacizumab; Roche/Chugai) is a humanized immunoglobulin G1 monoclonal antibody directed against vascular endothelial growth factor (VEGF). The VEGF protein is an essential component of the angiogenesis pathway, critical for blood vessel formation, facilitating tumor growth, invasion, and metastasis. Inhibiting the VEGF protein leads to decreased blood vessel formation, thereby restricting nutrient intake and limiting tumor growth and development. In the US, Avastin is currently approved for the treatment of renal cell carcinoma, colorectal cancer, non-small cell lung cancer, glioblastoma, cervical cancer, and ovarian cancer.
Avastin (bevacizumab; Roche/Chugai) has low commercial potential in the triple-negative breast cancer (TNBC) market. The US marketing approval was revoked in November 2011, shutting Avastin out of the most lucrative TNBC market, although some off-label prescribing still occurs. Additionally, while Avastin still has a broad approval for treatment of metastatic breast cancer irrespective of biomarker status in Europe and Japan, competition from the introduction of biosimilars and from more effective and safer treatments will steadily diminish its market share. Furthermore, Avastin’s commercial potential in the UK is also limited by reimbursement rejections from the National Institute for Health and Care Excellence (NICE)
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Avastin : Breast cancer: triple-negative
16 Avastin : Renal cell carcinoma (RCC)
27 Avastin : Non-small cell lung cancer (NSCLC)
44 Avastin : Colorectal cancer (CRC)
61 Avastin : Retinal disorders
72 Avastin : Ovarian cancer
88 Avastin : Breast cancer: HR+/HER2-
LIST OF FIGURES
13 Figure 1: Datamonitor Healthcare’s drug assessment summary of Avastin for TNBC
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Avastin for TNBC
20 Figure 3: Avastin for RCC – SWOT analysis
21 Figure 4: Datamonitor Healthcare’s drug assessment summary of Avastin for RCC
22 Figure 5: Datamonitor Healthcare’s drug assessment summary of Avastin for RCC
24 Figure 6: Avastin sales for RCC across the US, Japan, and five major EU markets, by country, 2017–26
35 Figure 7: Avastin for non-small cell lung cancer – SWOT analysis
36 Figure 8: Datamonitor Healthcare’s drug assessment summary for Avastin in non-small cell lung cancer
37 Figure 9: Datamonitor Healthcare’s drug assessment summary for Avastin in non-small cell lung cancer
39 Figure 10: Avastin sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
51 Figure 11: Avastin for colorectal cancer – SWOT analysis
52 Figure 12: Datamonitor Healthcare’s drug assessment summary of Avastin for colorectal cancer
53 Figure 13: Datamonitor Healthcare’s drug assessment summary of Avastin for colorectal cancer
55 Figure 14: Avastin sales for colorectal cancer across the US, Japan, and five major EU markets, by country, 2016–25
67 Figure 15: Avastin for retinal disorders – SWOT analysis
68 Figure 16: Datamonitor Healthcare’s drug assessment summary for Avastin in retinal disorders
69 Figure 17: Datamonitor Healthcare’s drug assessment summary for Avastin in retinal disorders
80 Figure 18: Avastin for ovarian cancer – SWOT analysis
81 Figure 19: Datamonitor Healthcare’s drug assessment of Avastin for ovarian cancer
82 Figure 20: Datamonitor Healthcare’s drug assessment of Avastin for ovarian cancer
98 Figure 21: Avastin for HR+/HER2- breast cancer – SWOT analysis
99 Figure 22: Datamonitor Healthcare’s drug assessment summary of Avastin in HR+/HER2- breast cancer
100 Figure 23: Datamonitor Healthcare’s drug assessment summary of Avastin in HR+/HER2- breast cancer
LIST OF TABLES
6 Table 1: Avastin drug profile
8 Table 2: Approval history of Avastin for TNBC in the US, Japan, and five major European markets
10 Table 3: Late-phase trials of Avastin for TNBC
12 Table 4: Avastin for TNBC – SWOT analysis
16 Table 5: Avastin drug profile
18 Table 6: Avastin Phase III data in RCC
25 Table 7: Avastin sales for RCC across the US, Japan, and five major EU markets, by country ($m), 2017–26
27 Table 8: Avastin drug profile
29 Table 9: Avastin pivotal trial data in non-small cell lung cancer
32 Table 10: Avastin late-phase trial data in non-small cell lung cancer
40 Table 11: Avastin sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
42 Table 12: Avastin patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
45 Table 13: Avastin drug profile
46 Table 14: Overview of major approvals for Avastin in colorectal cancer
47 Table 15: Avastin Phase III data in colorectal cancer
56 Table 16: Avastin sales for colorectal cancer across the US, Japan, and five major EU markets, by country ($m), 2016–25
58 Table 17: Patients treated with Avastin across the US, Japan, and five major EU markets, by country, 2016–25
62 Table 18: Avastin drug profile
64 Table 19: Avastin late-phase trial data in retinal disorders
66 Table 20: Avastin ongoing late-phase clinical trial in retinal disorders
73 Table 21: Avastin drug profile
75 Table 22: Avastin pivotal trial data in ovarian cancer
78 Table 23: Avastin late-phase trial data in ovarian cancer
79 Table 24: Avastin ongoing Phase III clinical trials in ovarian cancer
89 Table 25: Avastin drug profile
91 Table 26: Avastin pivotal trial data in HR+/HER2- breast cancer
96 Table 27: Avastin late-phase trial data in HR+/HER2- breast cancer
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