Drug Summary
Pfizer's IBRANCE (palbociclib) is a kinase inhibitor approved in the US by the FDA, in Europe by the EMA, and in Japan by the PMDA for the treatment of adult patients with HR+ HER2− advanced or metastatic breast cancer in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy in postmenopausal women or men or fulvestrant in patients with disease progression following endocrine therapy. IBRANCE is currently approved in more than 90 countries.It is used to treat HR+, HER2-advanced, or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or men; or fulvestrant in patients with disease progression following endocrine therapy.
The company is currently conducting a randomized, open-label, multicentric Phase III trial in patients receiving AI and palbociclib as first-line therapy for ER+/HER2-metastatic breast cancer. The study aims to evaluate, at the onset of ESR1 mutations in circulating tumor DNA, the efficacy of a change in hormone therapy (AI changed to fulvestrant) combined with palbociclib, together with the safety of the hormone therapy and palbociclib combination in the overall population.
- Dosage and Administration
- Recommended starting dose: 125 mg once daily, taken with food for 21 days, followed by 7 days off-treatment.
- Dosing interruptions and/or dose reductions are recommended based on individual safety and tolerability.
- Mechanism of Action
ER+ breast cancer cell lines combined with palbociclib and anti-estrogens led to increased cell senescence compared to each drug alone, which was sustained for up to 6 days following palbociclib removal and was greater if anti-estrogen treatment was continued. In vivo studies using a patient-derived ER+ breast cancer xenograft model demonstrated that the combination of palbociclib and letrozole increased the inhibition of Rb phosphorylation, downstream signaling, and tumor growth compared to each drug alone.
Scope of the Report
The report provides insights into:
- A comprehensive product overview including the IBRANCE description, mechanism of action, dosage and administration, research and development activities in ER+ve HER2-ve Breast Cancer.
- Elaborated details on IBRANCE regulatory milestones and other development activities have been provided in this report.
- The report also highlights the IBRANCE 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 IBRANCE.
- The report contains forecasted sales of IBRANCE 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 IBRANCE 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.IBRANCE Analytical Perspective
In-depth IBRANCE Market Assessment
This report provides a detailed market assessment of IBRANCE in ER+ve HER2-ve Breast Cancer in the United States. This segment of the report provides forecasted sales data from 2023 to 2032.IBRANCE Clinical Assessment
The report provides the clinical trials information of IBRANCE 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 IBRANCE dominance.
- Other emerging products for ER+ve HER2-ve Breast Cancer are expected to give tough market competition to IBRANCE 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 IBRANCE 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 IBRANCE in ER+ve HER2-ve Breast Cancer.
Key Questions Answered
- What is the product type, route of administration and mechanism of action of IBRANCE?
- What is the clinical trial status of the study related to IBRANCE 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 IBRANCE development?
- What are the key designations that have been granted to IBRANCE for ER+ve HER2-ve Breast Cancer?
- What is the forecasted market scenario of IBRANCE for ER+ve HER2-ve Breast Cancer?
- What are the forecasted sales of IBRANCE 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 IBRANCE 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. IBRANCE 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 IBRANCE Market Assessment
5.1. Market Outlook of IBRANCE in ER+ve HER2-ve Breast Cancer
5.2. US Market Analysis
5.2.1. Market size of IBRANCE 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: IBRANCE, Clinical Trial Description, 2023
Table 2: IBRANCE : General Description
Table 3: Competitive Landscape (Marketed Therapies)
Table 4: Competitive Landscape (Late -stage Emerging Therapies)
Table 5: IBRANCE Market Size in the US, in USD million (2019-2032)
List of Figures
Figure 1: IBRANCE Market Size in the United States, USD million (2019-2032)