Treanda/Bendeka
Publisher: Datamonitor Healthcare
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Drug Overview
Treanda (bendamustine; Teva/Mundipharma/Eisai) is an intravenous cytotoxic agent. The exact mechanism of action of the drug is still not fully known, but it is a mechlorethamine derivative which has the ability to cause crosslinking between the DNA strands through covalent bond formation. Several pathways have been associated with the cytotoxic activity of Treanda, including the initiation of a p53-dependent stress response and apoptosis due to the induction of significant DNA strand breaks, the inhibition of mitotic checkpoints in the affected cells, and the induction of mitotic catastrophe.
Analyst Outlook
Treanda (bendamustine; Teva/Mundipharma/Eisai) is indicated in the EU for the treatment of newly diagnosed multiple myeloma (NDMM) in combination with prednisone (EMA, 2018; electronic Medicines Compendium, 2018). In the US, Datamonitor Healthcare’s MM primary research survey indicates significant off-label use of Treanda and its rapid-infusion formulation, Bendeka. In Japan, Treanda is also used off-label for the treatment of MM, and Datamonitor Healthcare expects that the potential approval of Bendeka for non-Hodgkin’s lymphoma (NHL) in the first half of 2023 will lead to its off-label use for MM. The generic version of bendamustine’s powdered formulation is expected to erode sales of Treanda, and to some extent Bendeka, in the US from 2019 onwards.
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Treanda : Multiple myeloma
19 Treanda : NHL: Mantle cell lymphoma (MCL)
29 Treanda/Bendeka : Chronic lymphocytic leukemia (CLL)
42 Treanda/Bendeka : NHL: Follicular lymphoma (FL)
LIST OF FIGURES
9 Figure 1: Treanda/Bendeka for multiple myeloma – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Treanda/Bendeka for multiple myeloma
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of Treanda/Bendeka for multiple myeloma
13 Figure 4: Treanda/Bendeka sales for multiple myeloma across the US, Japan, and five major EU markets, by country, 2017–26
23 Figure 5: Treanda for mantle cell lymphoma – SWOT analysis
24 Figure 6: Datamonitor Healthcare’s drug assessment summary of Treanda in mantle cell lymphoma
25 Figure 7: Datamonitor Healthcare’s drug assessment summary of Treanda in mantle cell lymphoma
35 Figure 8: Datamonitor Healthcare’s drug assessment summary of Treanda/Bendeka for CLL
36 Figure 9: Datamonitor Healthcare’s drug assessment summary of Treanda/Bendeka for CLL
38 Figure 10: Treanda sales for CLL across the US, Japan, and five major EU markets, by country, 2017–26
39 Figure 11: Bendeka sales for CLL in the US, 2017–26
49 Figure 12: Treanda/Bendeka for follicular lymphoma – SWOT analysis
50 Figure 13: Datamonitor Healthcare’s drug assessment summary of Treanda/Bendeka for follicular lymphoma
51 Figure 14: Datamonitor Healthcare’s drug assessment summary of Treanda/Bendeka for follicular lymphoma
53 Figure 15: Treanda/Bendeka sales for follicular lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: Treanda/Bendeka drug profile
8 Table 2: Treanda early-phase trial data in multiple myeloma
12 Table 3: Patients receiving Treanda or generic bendamustine in the five major EU markets (%), by country
14 Table 4: Treanda/Bendeka sales for multiple myeloma across the US, Japan, and five major EU markets, by country ($m), 2017–26
16 Table 5: Patients treated with Treanda/Bendeka across the US, Japan, and five major EU markets, by country, 2017–26
20 Table 6: Treanda drug profile
22 Table 7: Treanda pivotal trial data in mantle cell lymphoma
30 Table 8: Treanda/Bendeka drug profile
31 Table 9: Approval history of Treanda/Bendeka for CLL in the US, Japan, and five major EU markets
32 Table 10: Trials of Treanda for CLL
34 Table 11: Trials of Bendeka for CLL
34 Table 12: Treanda/Bendeka for CLL – SWOT analysis
37 Table 13: Uptake of generic bendamustine in the EU, by country
43 Table 14: Treanda/Bendeka drug profile
45 Table 15: Treanda/Bendeka pivotal trial data in follicular lymphoma
46 Table 16: Treanda/Bendeka other clinical trial data in follicular lymphoma
54 Table 17: Treanda/Bendeka sales for follicular lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
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