Drug Summary
AFINITOR (Everolimus) is a kinase inhibitor used for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2− negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole. The generics of AFINITOR entered the US market in 2019.Mechanism of Action
Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine-threonine kinase, downstream of the PI3K/AKT pathway. The mTOR pathway is dysregulated in several human cancers. Everolimus binds to an intracellular protein, FKBP-12, resulting in an inhibitory complex formation with mTOR complex 1 (mTORC1) and thus inhibition of mTOR kinase activity.Everolimus reduced the activity of S6 ribosomal protein kinase (S6K1) and eukaryotic elongation factor 4E-binding protein (4E-BP1), downstream effectors of mTOR, involved in protein synthesis. S6K1 is a substrate of mTORC1 and phosphorylates the activation domain 1 of the estrogen receptor which results in ligand-independent activation of the receptor.
In addition, everolimus inhibited the expression of hypoxia-inducible factor (e.g., HIF-1) and reduced the expression of vascular endothelial growth factor (VEGF). Constitutive activation of the PI3K/Akt/mTOR pathway can contribute to endocrine resistance in breast cancer. In vitro studies show that estrogen-dependent and HER2+ breast cancer cells are sensitive to the inhibitory effects of everolimus and that combination treatment with everolimus and Akt, HER2, or aromatase inhibitors enhances the anti-tumor activity of everolimus in a synergistic manner.
Two regulators of mTORC1 signaling are the oncogene suppressors tuberin-sclerosis complexes 1 and 2 (TSC1, TSC2). Loss or inactivation of either TSC1 or TSC2 leads to activation of downstream signaling. In TSC, a genetic disorder, inactivating mutations in either the TSC1 or the TSC2 gene lead to hamartoma formation throughout the body.
Scope of the Report
The report provides insights into:
- A comprehensive product overview including the AFINITOR description, mechanism of action, dosage and administration, research and development activities in ER+ve HER2-ve Breast Cancer.
- Elaborated details on AFINITOR regulatory milestones and other development activities have been provided in this report.
- The report also highlights the AFINITOR research and development activity in ER+ve HER2-ve Breast Cancer in detail across the United States.
- The report also covers the patents information with expiry timeline around AFINITOR.
- The report contains forecasted sales of AFINITOR for ER+ve HER2-ve Breast Cancer till 2032.
- Comprehensive coverage of the late-stage emerging therapies for ER+ve HER2-ve Breast Cancer.
- The report also features the SWOT analysis with analyst views for AFINITOR in ER+ve HER2-ve Breast Cancer.
Methodology
The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the research team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.AFINITOR Analytical Perspective
In-depth AFINITOR Market Assessment
This report provides a detailed market assessment of AFINITOR in ER+ve HER2-ve Breast Cancer in the United States. This segment of the report provides forecasted sales data from 2023 to 2032.AFINITOR Clinical Assessment
The report provides the clinical trials information of AFINITOR in ER+ve HER2-ve Breast Cancer covering trial interventions, trial conditions, trial status, start and completion dates.Report Highlights
- In the coming years, the market scenario for ER+ve HER2-ve Breast Cancer is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
- The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence AFINITOR dominance.
- Other emerging products for ER+ve HER2-ve Breast Cancer are expected to give tough market competition to AFINITOR and launch of late-stage emerging therapies in the near future will significantly impact the market.
- A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of AFINITOR in ER+ve HER2-ve Breast Cancer.
- This in-depth analysis of the forecasted sales data from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the AFINITOR in ER+ve HER2-ve Breast Cancer.
Key Questions Answered
- What is the product type, route of administration and mechanism of action of AFINITOR?
- What is the clinical trial status of the study related to AFINITOR in ER+ve HER2-ve Breast Cancer and study completion date?
- What are the key collaborations, mergers and acquisitions, licensing and other activities related to the AFINITOR development?
- What are the key designations that have been granted to AFINITOR for ER+ve HER2-ve Breast Cancer?
- What is the forecasted market scenario of AFINITOR for ER+ve HER2-ve Breast Cancer?
- What are the forecasted sales of AFINITOR in the United States?
- What are the other emerging products available in ER+ve HER2-ve Breast Cancer and how are they giving competition to AFINITOR for ER+ve HER2-ve Breast Cancer?
- Which are the late-stage emerging therapies under development for the treatment of ER+ve HER2-ve Breast Cancer?
This product will be delivered within 2 business days.
Table of Contents
1. Report Introduction2. AFINITOR Overview in ER+ve HER2-ve Breast Cancer
2.1. Product Detail
2.2. Clinical Development
2.2.1. Clinical studies
2.2.2. Clinical trials information
2.3. Regulatory milestones
2.4. Other Developmental Activities
2.5. Product Profile
3. Competitive Landscape (Marketed Therapies)
4. Competitive Landscape (Late-stage Emerging Therapies)
5 AFINITOR Market Assessment
5.1. Market Outlook of AFINITOR in ER+ve HER2-ve Breast Cancer
5.2. US Market Analysis
5.2.1. Market size of AFINITOR in the United States for ER+ve HER2-ve Breast Cancer
6. SWOT Analysis
7. Analysts’ Views
8. Appendix
8.1. Bibliography
8.2. Report Methodology
9. Publisher Capabilities
10. Disclaimer
11. About the Publisher
12. Report Purchase Options
List of Tables
Table 1: AFINITOR, Clinical Trial Description, 2023
Table 2: AFINITOR : General Description
Table 3: Competitive Landscape (Marketed Therapies)
Table 4: Competitive Landscape (Late -stage Emerging Therapies)
Table 5: AFINITOR Market Size in the US, in USD million (2019-2032)
List of Figures
Figure 1: AFINITOR Market Size in the United States, USD million (2019-2032)