Rituxan
Author: Michael Ramirez
Publisher: Datamonitor Healthcare
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Drug Overview
Rituxan (rituximab; Biogen/Roche/Chugai/Zenyaku Kogyo) is a murine/human chimeric cluster of differentiation (CD)20-targeted monoclonal antibody that is indicated for the treatment of a number of B-cell non-Hodgkin’s lymphomas and for rheumatoid arthritis patients who inadequately respond to anti-tumor necrosis factor therapy. Rituximab is marketed in the US by Roche’s Genentech subsidiary and Biogen under the Rituxan brand name. Outside the US, the drug is marketed by Roche as MabThera, and in Japan it is marketed by Chugai and Zenyaku Kogyo as Rituxan.
Despite failing to meet its primary endpoints in studies for systemic lupus erythematosus (SLE) patients, Rituxan continues to be considered an effective treatment option, specifically for those patients with more severe disease. Datamonitor Healthcare believes that Rituxan will continue to be used off-label; however, reimbursement has become more difficult following the approval of Benlysta (belimumab; GlaxoSmithKline), and this is expected to become even more restrictive as additional therapies receive approval for use in SLE. The 2017 arrival of a biosimilar version of Rituxan in the EU further dampens Rituxan’s commercial attractiveness.
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Off-label: Rituxan : Systemic lupus erythematosus (SLE)
17 Rituxan : Chronic lymphocytic leukemia (CLL)
30 Rituxan : NHL: Follicular lymphoma (FL)
45 Rituxan : NHL: Diffuse large B-cell lymphoma (DLBCL)
60 Rituxan : Rheumatoid arthritis (RA)
72 Rituxan : NHL: Mantle cell lymphoma (MCL)
LIST OF FIGURES
10 Figure 1: Rituxan for SLE – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of Rituxan for SLE
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of Rituxan for SLE
14 Figure 4: Rituxan sales for SLE across the US and five major EU markets, by region, 2016–25
24 Figure 5: Datamonitor Healthcare’s drug assessment summary of Rituxan for CLL
25 Figure 6: Datamonitor Healthcare’s drug assessment summary of Rituxan for CLL
28 Figure 7: Rituxan sales for CLL across the US, Japan, and five major EU markets, by country, 2017–26
37 Figure 8: Rituxan for follicular lymphoma – SWOT analysis
38 Figure 9: Datamonitor Healthcare’s drug assessment summary of Rituxan for follicular lymphoma
39 Figure 10: Datamonitor Healthcare’s drug assessment summary of Rituxan for follicular lymphoma
41 Figure 11: Rituxan sales for follicular lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
51 Figure 12: Rituxan for diffuse large B-cell lymphoma – SWOT analysis
52 Figure 13: Datamonitor Healthcare’s drug assessment summary for Rituxan in diffuse large B-cell lymphoma
53 Figure 14: Datamonitor Healthcare’s drug assessment summary for Rituxan in diffuse large B-cell lymphoma
56 Figure 15: Rituxan sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
68 Figure 16: Rituxan for rheumatoid arthritis – SWOT analysis
69 Figure 17: Datamonitor Healthcare’s drug assessment summary of Rituxan in rheumatoid arthritis
70 Figure 18: Datamonitor Healthcare’s drug assessment summary of Rituxan in rheumatoid arthritis
77 Figure 19: Rituxan for mantle cell lymphoma – SWOT analysis
78 Figure 20: Datamonitor Healthcare’s drug assessment summary of Rituxan in mantle cell lymphoma
79 Figure 21: Datamonitor Healthcare’s drug assessment summary of Rituxan in mantle cell lymphoma
LIST OF TABLES
6 Table 1: Rituxan drug profile
8 Table 2: Rituxan pivotal trial data in SLE
15 Table 3: Rituxan sales for SLE across the US and five major EU markets, by region ($m), 2016–25
17 Table 4: Rituxan drug profile
18 Table 5: Approval history of Rituxan for CLL in the US, Japan, and five major EU markets
20 Table 6: Trials of Rituxan for CLL
23 Table 7: Rituxan for CLL – SWOT analysis
30 Table 8: Rituxan drug profile
32 Table 9: Rituxan pivotal trial data in follicular lymphoma
36 Table 10: Rituxan other clinical trial data in follicular lymphoma
42 Table 11: Rituxan sales for follicular lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
45 Table 12: Rituxan drug profile
47 Table 13: Rituxan pivotal trial data in diffuse large B-cell lymphoma
50 Table 14: Rituxan Phase III data in diffuse large B-cell lymphoma
57 Table 15: Rituxan sales for diffuse large B-cell lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
61 Table 16: Rituxan drug profile
63 Table 17: Rituxan pivotal trial data in rheumatoid arthritis
66 Table 18: Rituxan late-phase trial data in rheumatoid arthritis
73 Table 19: Rituxan drug profile
74 Table 20: Rituxan pivotal trial data in B-cell non-Hodgkin’s lymphoma
76 Table 21: Rituxan clinical studies in mantle cell lymphoma
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