Bladder cancer is the fifth most common cancer in Europe and the ninth most common cancer globally. Symptoms include hematuria, dysuria, increased urinary frequency, and frequent urinary tract infections.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Risk factors
9 Symptoms
10 Diagnosis
11 Patient segmentation
11 Prognosis
13 TREATMENT
13 Referral patterns
13 Non-muscle invasive bladder cancer (Stage 0–I)
13 Muscle invasive bladder cancer (Stage II–III)
14 Metastatic (Stage IV)
18 EPIDEMIOLOGY
22 MARKETED DRUGS
26 PIPELINE DRUGS
38 KEY REGULATORY EVENTS
38 Enfortumab Vedotin Set For CHMP Opinion
38 Pause On EU Plans For Vysyneum
38 Keytruda’s Urothelial Cancer Claim Goes From Accelerated To Full Approval, With More Limited Scope
38 Where Next For Sesen Bio’s Bladder Cancer Therapy Vicineum?
39 Bladder Cancer Accelerated Approvals: Merck, Genentech PD-1/L1 Inhibitors Prevail At US FDA Panel, But For Different Reasons
39 Bladder Cancer Accelerated Approvals: Merck’s Keytruda and Genentech’s Tecentriq Each May Have One Last Lifeline
40 Bladder Cancer Space Churns With Accelerated Approvals
40 Accelerated Approval: US FDA Review Of Expedited Program Could Bring More Withdrawals
40 Keeping Track: Padcev, Vicineum Seek Bladder Cancer Approvals
42 PROBABILITY OF SUCCESS
43 LICENSING AND ASSET ACQUISITION DEALS
43 GSK Exits $4.2bn Cancer Drug Deal With Merck KGaA After Multiple Failures
43 Trigone Pharma Collaborates With 4C Biomed
43 Oncology Accelerates In China As Large Makers Hunt For Assets
43 CytoImmune Acquires City Of Hope Cell Therapy IP
44 Helsinn And BridgeBio Ink Infigratinib Cancer Pact
44 U. Of Texas Research Branch Maintains Hectic Partnering Pace
45 CLINICAL TRIAL LANDSCAPE
46 Sponsors by status
47 Sponsors by phase
48 Recent events
49 DRUG ASSESSMENT MODEL
53 MARKET DYNAMICS
54 FUTURE TRENDS
54 Platinum-eligible first-line mUC remains out of reach for PD-1/PD-L1 antibodies
54 Regulatory reviews threaten use of PD-1/PD-L1 antibodies in mUC
55 PD-1/PD-L1 inhibitors move to earlier, more localized bladder tumors
55 Multiple novel agents are targeting the lucrative NMIBC setting
56 Development of FGFR inhibitors sees mixed fortunes
56 Antibody-drug conjugates may diversify treatment for metastatic bladder cancer
57 CONSENSUS FORECASTS
59 RECENT EVENTS AND ANALYST OPINION
59 Multiple Drugs for Bladder Cancer (February 18, 2022)
59 BT8009 for Bladder Cancer (October 7, 2021)
60 Vicineum for Bladder Cancer (August 13, 2021)
61 Keytruda for Bladder Cancer (April 28, 2021)
63 Tecentriq for Bladder Cancer (April 28, 2021)
65 Keytruda for Bladder Cancer (April 23, 2021)
66 Tecentriq for Bladder Cancer (April 23, 2021)
67 Eganelisib for Bladder Cancer (February 11, 2021)
68 Anktiva for Bladder Cancer (December 21, 2020)
69 Padcev for Bladder Cancer (October 12, 2020)
72 KEY UPCOMING EVENTS
73 UNMET NEEDS
74 KEY OPINION LEADER INSIGHTS
75 BIBLIOGRAPHY
77 APPENDIX
LIST OF FIGURES
20 Figure 1: Trends in incident cases of bladder cancer, 2018–27
26 Figure 2: Overview of pipeline drugs for bladder cancer in the US
26 Figure 3: Pipeline drugs for bladder cancer, by company
27 Figure 4: Pipeline drugs for bladder cancer, by drug type
27 Figure 5: Pipeline drugs for bladder cancer, by classification
42 Figure 6: Probability of success in the bladder cancer pipeline
45 Figure 7: Clinical trials in bladder cancer
45 Figure 8: Top 10 drugs for clinical trials in bladder cancer
46 Figure 9: Top 10 companies for clinical trials in bladder cancer
46 Figure 10: Trial locations in bladder cancer
47 Figure 11: Bladder cancer trials status
48 Figure 12: Bladder cancer trials sponsors, by phase
49 Figure 13: Datamonitor Healthcare’s drug assessment summary for bladder cancer
53 Figure 14: Market dynamics for bladder cancer
54 Figure 15: Future trends in bladder cancer
68 Figure 16: Eganelisib for Bladder Cancer (February 11, 2021): Phase II – MARIO-275 (w/Nivolumab)
71 Figure 17: Padcev for Bladder Cancer (October 12, 2020): Phase II – EV-201
72 Figure 18: Key upcoming events in bladder cancer
LIST OF TABLES
11 Table 1: Bladder cancer staging
12 Table 2: Five-year survival rates for bladder cancer by stage at diagnosis
16 Table 3: Preferred branded treatment regimens for patients with Stage IV bladder cancer
19 Table 4: Incident cases of bladder cancer, 2018–27
21 Table 5: Incident cases of bladder cancer, by gender, 2018
23 Table 6: Marketed drugs for bladder cancer
28 Table 7: Pipeline drugs for bladder cancer in the US
57 Table 8: Historical global sales, by drug ($m), 2016–20
58 Table 9: Forecasted global sales, by drug ($m), 2022–26
59 Table 10: Multiple Drugs for Bladder Cancer (February 18, 2022)
60 Table 11: BT8009 for Bladder Cancer (October 7, 2021)
61 Table 12: Vicineum for Bladder Cancer (August 13, 2021)
62 Table 13: Keytruda for Bladder Cancer (April 28, 2021)
64 Table 14: Tecentriq for Bladder Cancer (April 28, 2021)
65 Table 15: Keytruda for Bladder Cancer (April 23, 2021)
66 Table 16: Tecentriq for Bladder Cancer (April 23, 2021)
67 Table 17: Eganelisib for Bladder Cancer (February 11, 2021)
69 Table 18: Anktiva for Bladder Cancer (December 21, 2020)
70 Table 19: Padcev for Bladder Cancer (October 12, 2020)
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