Chronic myeloid leukemia (CML) is defined as a cancer of the blood in which a mutation in myeloid hematopoietic stem cells causes the overproduction of immature and dysfunctional white blood cells (myeloblasts, also known as blasts), preventing the normal production and function of healthy white blood cells, red blood cells, and platelets. CML is a progressive disease that occurs in all age groups; however, it is most common in older adults, with a median age at diagnosis of 64 years.
CONTENTS
6 OVERVIEW
6 Latest key takeaways
8 DISEASE BACKGROUND
8 Definition
8 Risk factors
8 Patient segmentation
9 Symptoms
10 Diagnosis
11 Prognosis
12 TREATMENT
12 Prognostic scoring systems
13 Chronic phase first-line treatment
14 Advanced phase first-line treatment
14 Response milestones after first-line TKI therapy
16 Mutational analysis
16 Allogeneic HSCT
18 EPIDEMIOLOGY
18 Incidence methodology
21 MARKETED DRUGS
26 PIPELINE DRUGS
31 KEY REGULATORY EVENTS
31 Scemblix Receives Approval In South Korea
31 CHMP Recommends Scemblix For Approval In EU
31 Accord Generics Endorsed By CHMP
31 New Submissions Under FDA Review
31 Novartis Builds On Its Legacy With Scemblix Approval For CML
32 Novartis Files Asciminib For Approval In US and EU
33 PROBABILITY OF SUCCESS
34 CLINICAL TRIAL LANDSCAPE
35 Sponsors by status
36 Sponsors by phase
38 DRUG ASSESSMENT MODEL
42 MARKET DYNAMICS
43 FUTURE TRENDS
43 Generic erosion of key brands will continue to have an impact on growth
43 Scemblix will dominate the third-line setting
43 Scemblix and Iclusig will compete for market share in the T315I mutation-positive patient subgroup
45 CONSENSUS FORECASTS
47 RECENT EVENTS AND ANALYST OPINION
47 Scemblix for Chronic Myelogenous Leukemia (CML) (December 11, 2021)
48 Iclusig for Chronic Myelogenous Leukemia (CML) (May 19, 2021)
51 KEY UPCOMING EVENTS
52 KEY OPINION LEADER INSIGHTS
54 UNMET NEEDS
55 BIBLIOGRAPHY
57 APPENDIX
LIST OF FIGURES
15 Figure 1: Levels of molecular response in CML
20 Figure 2: Trends in incident cases of CML, 2018–27
26 Figure 3: Overview of pipeline drugs for CML in the US
26 Figure 4: Pipeline drugs for CML, by company
27 Figure 5: Pipeline drugs for CML, by drug type
27 Figure 6: Pipeline drugs for CML, by classification
33 Figure 7: Probability of success in the hematologic pipeline
34 Figure 8: Clinical trials in CML
34 Figure 9: Top 10 drugs for clinical trials in CML
35 Figure 10: Top 10 companies for clinical trials in CML
35 Figure 11: Trial locations in CML
36 Figure 12: CML trials status
37 Figure 13: CML trials sponsors, by phase
38 Figure 14: Datamonitor Healthcare’s drug assessment summary for CML
42 Figure 15: Market dynamics in CML
43 Figure 16: Future trends in CML
48 Figure 17: Scemblix for Chronic Myelogenous Leukemia (CML) (December 11, 2021): Phase III – ASCEMBL
51 Figure 18: Key upcoming events in CML
LIST OF TABLES
9 Table 1: Definitions of CML, by phase
13 Table 2: Prognostic scoring systems for CML
15 Table 3: Levels of cytogenetic response in CML
16 Table 4: Contraindicated mutations for specific CML treatments
19 Table 5: Incident cases of CML, 2018–27
22 Table 6: Marketed drugs for CML
28 Table 7: Pipeline drugs for CML in the US
45 Table 8: Historical global sales, by drug ($m), 2017–21
46 Table 9: Forecasted global sales, by drug ($m), 2022–26
47 Table 10: Scemblix for Chronic Myelogenous Leukemia (CML) (December 11, 2021)
49 Table 11: Iclusig for Chronic Myelogenous Leukemia (CML) (May 19, 2021)
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