Drug Summary
ROZLYTREK (entrectinib) is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. ROZLYTREK can block ROS1 and NTRK kinase activity and may lead to the death of cancer cells with ROS1 or NTRK gene fusions.It is used to treat the adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
Dosage and Administration
Recommended Dosage for NTRK Gene Fusion-Positive Solid Tumors:Adults: 600 mg orally once in a day.
Pediatric Patients 12 years and older: Recommended dosage is based on body surface area (BSA) as shown below
- BSA greater than 1.50 m2: 600 mg once in a day.
- BSA 1.11-1.50 m2: 500 mg once in a day.
- BSA 0.91-1.10 m2: 400 mg once in a day.
Mechanism of Action
Entrectinib is an inhibitor of tropomyosin receptor tyrosine kinases (TRK) TRKA, TRKB, and TRKC (encoded by the neurotrophic tyrosine receptor kinase [NTRK] genes NTRK1, NTRK2, and NTRK3, respectively), proto-oncogene, tyrosine-protein kinase ROS1 (ROS1), and anaplastic lymphoma kinase (ALK) with IC50 values of 0.1-2 nM. Entrectinib also inhibits JAK2 and TNK2 with IC50 values >5 nM. The major active metabolite of entrectinib, M5, showed similar in vitro activity against TRK, ROS1, and ALK.Fusion proteins that include TRK, ROS1, or ALK kinase domains can drive tumorigenic potential through hyperactivation of downstream signaling pathways leading to unconstrained cell proliferation. Entrectinib demonstrated in vitro and in vivo inhibition of cancer cell lines derived from multiple tumor types harboring NTRK, ROS1, and ALK fusion genes.
Entrectinib demonstrated steady-state brain-to-plasma concentration ratios of 0.4-2.2 in multiple animal species (mice, rats, and dogs) and demonstrated in vivo antitumor activity in mice with intracranial implantation of TRKA- and ALK-driven tumor cell lines.
Scope of the Report
The report provides insights into:
- A comprehensive product overview including the ROZLYTREK description, mechanism of action, dosage and administration, research and development activities in pancreatic cancer.
- Elaborated details on ROZLYTREK regulatory milestones and other development activities have been provided in this report.
- The report also highlights the ROZLYTREK research and development activities in pancreatic cancer across the United States, Europe and Japan.
- The report also covers the patents information with expiry timeline around ROZLYTREK.
- The report contains forecasted sales of for pancreatic cancer till 2032.
- Comprehensive coverage of the late-stage emerging therapies for pancreatic cancer.
- The report also features the SWOT analysis with analyst views for ROZLYTREK in pancreatic 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.ROZLYTREK Analytical Perspective
In-depth ROZLYTREK Market Assessment
This report provides a detailed market assessment of ROZLYTREK for pancreatic cancer in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2023 to 2032.ROZLYTREK Clinical Assessment
The report provides the clinical trials information of ROZLYTREK for pancreatic cancer covering trial interventions, trial conditions, trial status, start and completion dates.Report Highlights
- In the coming years, the market scenario for pancreatic 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.
- Other emerging products for pancreatic cancer are expected to give tough market competition to ROZLYTREK 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 ROZLYTREK in pancreatic cancer.
- The in-depth analysis of the forecasted sales data of ROZLYTREK from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the ROZLYTREK in pancreatic cancer.
Key Questions Answered
- What is the product type, route of administration and mechanism of action of ROZLYTREK?
- What is the clinical trial status of the study related to ROZLYTREK in pancreatic cancer and study completion date?
- What are the key collaborations, mergers and acquisitions, licensing and other activities related to the ROZLYTREK development?
- What are the key designations that have been granted to ROZLYTREK for pancreatic cancer?
- What is the forecasted market scenario of ROZLYTREK for pancreatic cancer?
- What are the forecasted sales of ROZLYTREK in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
- What are the other emerging products available and how are these giving competition to ROZLYTREK for pancreatic cancer?
- Which are the late-stage emerging therapies under development for the treatment of pancreatic cancer?
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Table of Contents
1. Report Introduction2. ROZLYTREK Overview in Pancreatic Cancer
2.1. Product Detail
2.2. Clinical Development
2.2.1. Clinical studies
2.2.2. Clinical trials information
2.2.3. Safety and efficacy
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. ROZLYTREK Market Assessment
5.1. Market Outlook of ROZLYTREK in Pancreatic Cancer
5.2. 7MM Analysis
5.2.1. Market size of ROZLYTREK in the 7MM for pancreatic cancer
5.3. Country-wise Market Analysis
5.3.1. Market size of ROZLYTREK in the United States for pancreatic cancer
5.3.2. Market size of ROZLYTREK in Germany for pancreatic cancer
5.3.3. Market size of ROZLYTREK in France for pancreatic cancer
5.3.4. Market size of ROZLYTREK in Italy for pancreatic cancer
5.3.5. Market size of ROZLYTREK in Spain for pancreatic cancer
5.3.6. Market size of ROZLYTREK in the United Kingdom for pancreatic cancer
5.3.7. Market size of ROZLYTREK in Japan for pancreatic 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: ROZLYTREK, Clinical Trial Description, 2023
Table 2: ROZLYTREK, General Description
Table 3: Competitive Landscape (Marketed Therapies)
Table 4: Competitive Landscape (Emerging Therapies)
Table 5: ROZLYTREK Market Size in the 7MM, in USD million (2019-2032)
Table 6: ROZLYTREK Market Size in the US, in USD million (2019-2032)
Table 7: ROZLYTREK Market Size in Germany, in USD million (2019-2032)
Table 8: ROZLYTREK Market Size in France, in USD million (2019-2032)
Table 9: ROZLYTREK Market Size in Italy, in USD million (2019-2032)
Table 10: ROZLYTREK Market Size in Spain, in USD million (2019-2032)
Table 11: ROZLYTREK Market Size in the UK, in USD million (2019-2032)
Table 12: ROZLYTREK Market Size in Japan, in USD million (2019-2032)
List of Figures
Figure 1: ROZLYTREK Market Size in the 7MM, USD million (2019-2032)
Figure 2: ROZLYTREK Market Size in the United States, USD million (2019-2032)
Figure 3: ROZLYTREK Market Size in Germany, USD million (2019-2032)
Figure 4: ROZLYTREK Market Size in France, USD million (2019-2032)
Figure 5: ROZLYTREK Market Size in Italy, USD million (2019-2032)
Figure 6: ROZLYTREK Market Size in Spain, USD million (2019-2032)
Figure 7: ROZLYTREK Market Size in the United Kingdom, USD million (2019-2032)
Figure 8: ROZLYTREK Market Size in Japan, USD million (2019-2032)