Follicular lymphoma (FL) is an indolent subtype of non-Hodgkin’s lymphoma (NHL) specifically originating from centrocyte and centroblast B cells and usually beginning in the lymph nodes. The disease is among the most common forms of NHL alongside diffuse
large B-cell lymphoma (DLBCL), accounting for approximately 35% of all NHLs.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Risk factors
9 Symptoms
10 Diagnosis
10 Patient segmentation
12 Prognosis
14 TREATMENT
14 Standard therapeutic techniques
14 Recommended first-line pharmacological regimens
15 Recommended subsequent-line pharmacological regimens
19 EPIDEMIOLOGY
19 Incidence methodology
22 MARKETED DRUGS
27 PIPELINE DRUGS
34 KEY REGULATORY EVENTS
34 Roche Initiates Rolling BLA For Mosunetuzumab
34 Future Of TG’s Ukoniq In Question As Drug Attracts Closer FDA Scrutiny
34 Incyte Pulls Parsaclisib Files As FDA Takes Foot Off Accelerator
35 Accord’s UK Lenalidomide Launch Kicks Off A Year Of Revlimid Competition
35 ‘Dangling’ Cancer Indications In US: New Year Brings New Withdrawals Of Accelerated Approvals
35 Accelerated Assessment Success In EU For CSL Behring And Roche
36 Kymriah sBLA Heats Up CAR-T Follicular Lymphoma Battle
36 Roche Among EU Fast-Track Hopefuls With Lymphoma Bispecific Mosunetuzumab
37 Two Review Tracks, One Approval For TG’s Ukoniq
38 PROBABILITY OF SUCCESS
39 LICENSING AND ASSET ACQUISITION DEALS
39 Hengrui Teams Up With Mabworks In Asset-For-Shareholding Deal
39 Pfizer To Buy Trillium For $2.26bn In A Hematology Pipeline Play
39 HUTCHMED To Develop Epizyme’s Tazverik For China Market
40 CLINICAL TRIAL LANDSCAPE
42 Sponsors by status
42 Sponsors by phase
43 Recent events
47 DRUG ASSESSMENT MODEL
51 MARKET DYNAMICS
52 FUTURE TRENDS
52 Proliferation of novel therapies in relapsed/recurrent disease
53 Rituximab to remain staple treatment in front-line patients
53 Potential changes to second-line treatment landscape
54 CONSENSUS FORECASTS
59 RECENT EVENTS AND ANALYST OPINION
59 Mosunetuzumab for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 11, 2021)
60 Zandelisib for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (November 30, 2021)
62 Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (April 10, 2021)
64 Odronextamab for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 14, 2020)
66 Ukoniq for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 7, 2020)
67 Parsaclisib for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 7, 2020)
69 Kymriah for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 5, 2020)
70 Yescarta for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 5, 2020)
71 HMPL-689 for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 5, 2020)
72 Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (October 14, 2020)
75 KEY UPCOMING EVENTS
76 KEY OPINION LEADER INSIGHTS
77 UNMET NEEDS
78 BIBLIOGRAPHY
79 APPENDIX
LIST OF FIGURES
11 Figure 1: Lugano Staging Classification for follicular lymphoma
13 Figure 2: Incidence rate and death rate of follicular lymphoma in the US, 1992–2018
15 Figure 3: Recommended first-line therapies for follicular lymphoma
16 Figure 4: Recommended subsequent-line therapies for follicular lymphoma
21 Figure 5: Trends in incident cases of follicular lymphoma, 2018–27
27 Figure 6: Overview of pipeline drugs for follicular lymphoma in the US
27 Figure 7: Pipeline drugs for follicular lymphoma, by company
28 Figure 8: Pipeline drugs for follicular lymphoma, by drug type
28 Figure 9: Pipeline drugs for follicular lymphoma, by classification
38 Figure 10: Probability of success in the indolent NHL (including follicular lymphoma) pipeline
40 Figure 11: Clinical trials in non-Hodgkin’s lymphoma
40 Figure 12: Top 10 drugs for clinical trials in non-Hodgkin’s lymphoma
41 Figure 13: Top 10 companies for clinical trials in non-Hodgkin’s lymphoma
41 Figure 14: Trial locations in non-Hodgkin’s lymphoma
42 Figure 15: Non-Hodgkin’s lymphoma trials status
43 Figure 16: Non-Hodgkin’s lymphoma trials sponsors, by phase
47 Figure 17: Datamonitor Healthcare’s drug assessment summary for follicular lymphoma
51 Figure 18: Market dynamics in follicular lymphoma
52 Figure 19: Future trends in follicular lymphoma
60 Figure 20: Mosunetuzumab for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 11, 2021)
62 Figure 21: Zandelisib for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (November 30, 2021): Phase II – TIDAL
64 Figure 22: Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (April 10, 2021): Phase III – CHRONOS-3
67 Figure 23: Ukoniq for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 7, 2020): Phase II/III – UNITY-NHL
69 Figure 24: Parsaclisib for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 7, 2020): Phase II – CITADEL-203 (vs. Idelalisib)
74 Figure 25: Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (October 14, 2020): Phase III – CHRONOS-3
75 Figure 26: Key upcoming events in follicular lymphoma
LIST OF TABLES
12 Table 1: WHO histologic grading system for follicular lymphoma
17 Table 2: Recommended branded treatment regimens for follicular lymphoma
20 Table 3: Incident cases of follicular lymphoma, 2018–27
23 Table 4: Marketed drugs for follicular lymphoma
29 Table 5: Pipeline drugs for follicular lymphoma in the US
55 Table 6: Historical global sales, by drug ($m), 2016–20
57 Table 7: Forecasted global sales, by drug ($m), 2022–26
59 Table 8: Mosunetuzumab for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 11, 2021)
61 Table 9: Zandelisib for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (November 30, 2021)
63 Table 10: Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (April 10, 2021)
65 Table 11: Odronextamab for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 14, 2020)
66 Table 12: Ukoniq for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 7, 2020)
68 Table 13: Parsaclisib for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 7, 2020)
70 Table 14: Kymriah for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 5, 2020)
71 Table 15: Yescarta for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 5, 2020)
72 Table 16: HMPL-689 for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (December 5, 2020)
73 Table 17: Aliqopa for Indolent Non-Hodgkin’s Lymphoma (Including Follicular Lymphoma) – NHL (October 14, 2020)
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