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Mivavotinib Emerging Drug Insight and Market Forecast - 2032
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"Mivavotinib Emerging Drug Insight and Market Forecast - 2032" report provides comprehensive insights about mivavotinib for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets. A detailed picture of the mivavotinib for DLBCL in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019 -2032 is provided in this report along with a detailed description of the mivavotinib for DLBCL. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the mivavotinib market forecast analysis for DLBCL in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in DLBCL.

Drug Summary:

Mivavotinib (CB-659, formerly known as TAK-659) is an SYK inhibitor that targets the constitutively activated B-cell receptor (BCR) pathway in DLBCL and other NHL. It has durable single-agent responses in unselected R/R DLBCL. Clinical data show mivavotinib is differentiated from other SYK inhibitors, as it showed substantially higher single-agent response rates than other SYK inhibitors, which had monotherapy response rates of <10% in similar DLBCL patient populations. In separate preclinical experiments, mivavotinib showed high tissue distribution, a large volume of distribution, and a high tumor plasma exposure ratio.

Calithera Biosciences is currently conducting a Phase II trial of mivavotinib in R/R non-GCB (ABC) DLBCL with enrichment of MYD88/CD79b mutated tumors. The company has experienced site activation delays on this trial, adversely affecting enrollment; as a result, initial data from this is unexpected to be available until mid-2023.

The Phase IIa portion of the study will confirm activity in the biomarker-defined subsets and refine the dose/schedule. The first patient was enrolled in June 2022. Data from Phase IIa will inform Phase IIb, which could be registration-enabling and potentially enroll expansion cohorts comprised of non-GCB (ABC) DLBCL and MyD88 and/or CD79m DLBCL, with a primary endpoint of ORR to target accelerated approval as a single agent in these biomarker-defined subsets.

Scope of the Report:

The report provides insights into:

Methodology:

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's 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.

Mivavotinib Analytical Perspective by DelveInsight

In-depth Mivavotinib Market Assessment

This report provides a detailed market assessment of mivavotinib for Diffuse Large B-cell lymphoma (DLBCL) 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 2026 to 2032.

Mivavotinib Clinical Assessment

The report provides the clinical trials information of mivavotinib for DLBCL covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

Key Questions:

Table of Contents

1. Report Introduction

2. Mivavotinib Overview in DLBCL

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. Mivavotinib Market Assessment

6. SWOT Analysis

7. Analysts' Views

8. Appendix

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options

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