Drug Summary
VERZENIO (Abemaciclib) is indicated for the treatment of women with HR+ in combination with fulvestrant.It is also used to treat HER2− advanced or metastatic breast cancer with disease progression following endocrine therapy. In addition, it is used as monotherapy for the treatment of adult patients with HR+, HER2− advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Dosage and Administration
- When used in combination with fulvestrant, the recommended dose of VERZENIO is 150 mg taken orally twice daily.
- When used as monotherapy, the recommended dose of VERZENIO is 200 mg taken orally twice daily. It is recommended to continue treatment until disease progression or unacceptable toxicity. VERZENIO may be taken with or without food.
Mechanism of Action
Abemaciclib is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). These kinases are activated upon binding to D-cyclins. In ER+ breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.In vitro, continuous exposure to abemaciclib inhibited Rb phosphorylation and blocked progression from G1 into the S phase of the cell cycle, resulting in senescence and apoptosis. In breast cancer xenograft models, abemaciclib dosed daily without interruption as a single agent or in combination with antiestrogens resulted in a reduction of tumor size.
Scope of the Report
The report provides insights into:
- A comprehensive product overview including the VERZENIO description, mechanism of action, dosage and administration, research and development activities in ER+ve HER2-ve Breast Cancer.
- Elaborated details on VERZENIO regulatory milestones and other development activities have been provided in this report.
- The report also highlights the VERZENIO 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 VERZENIO.
- The report contains forecasted sales of VERZENIO 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 VERZENIO 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.VERZENIO Analytical Perspective
In-depth VERZENIO Market Assessment
This report provides a detailed market assessment of VERZENIO in ER+ve HER2-ve Breast Cancer in the United States. This segment of the report provides forecasted sales data from 2023 to 2032.VERZENIO Clinical Assessment
The report provides the clinical trials information of VERZENIO 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 VERZENIO dominance.
- Other emerging products for ER+ve HER2-ve Breast Cancer are expected to give tough market competition to VERZENIO 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 VERZENIO 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 VERZENIO in ER+ve HER2-ve Breast Cancer.
Key Questions Answered
- What is the product type, route of administration and mechanism of action of VERZENIO?
- What is the clinical trial status of the study related to VERZENIO 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 VERZENIO development?
- What are the key designations that have been granted to VERZENIO for ER+ve HER2-ve Breast Cancer?
- What is the forecasted market scenario of VERZENIO for ER+ve HER2-ve Breast Cancer?
- What are the forecasted sales of VERZENIO 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 VERZENIO 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?
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Table of Contents
1. Report Introduction2. VERZENIO 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 VERZENIO Market Assessment
5.1. Market Outlook of VERZENIO in ER+ve HER2-ve Breast Cancer
5.2. US Market Analysis
5.2.1. Market size of VERZENIO 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: VERZENIO , Clinical Trial Description, 2023
Table 2: VERZENIO : General Description
Table 3: Competitive Landscape (Marketed Therapies)
Table 4: Competitive Landscape (Late -stage Emerging Therapies)
Table 5: VERZENIO Market Size in the US, in USD million (2019-2032)
List of Figures
Figure 1: VERZENIO Market Size in the United States, USD million (2019-2032)