Ublituximab (TG Therapeutics/LFB Biotechnologies) is an anti-CD20 monoclonal antibody, currently in late-stage trials across a range of hematological and neurological indications. CD20 is a cell-surface antigen expressed on most B cells, and the depletion of these cells suppresses the autoimmune response within both relapsing and progressive forms of multiple sclerosis (MS). Its primary indication is chronic lymphocytic leukemia (CLL), although the proof-of-concept for B-cell depletion established by Ocrevus in MS has encouraged TG Therapeutics to explore ublituximab’s broader clinical effect.
LFB Biotechnologies originally discovered ublituximab, and sold worldwide commercial rights to TG Therapeutics in 2012. TG Therapeutics subsequently initiated several clinical trials to support the development and eventual commercialization of ublituximab, its lead candidate. These include the Phase III GENUINE and UNITY programs in CLL and non-Hodgkin’s lymphoma, as well as the ULTIMATE I and II trials in relapsing MS. In southeast Asia and South Korea, TG Therapeutics has out-licensed ublituximab to Ildong.
Table of Contents
OVERVIEW
Drug Overview
Product Profiles
ublituximab: Chronic lymphocytic leukemia (CLL)
ublituximab: NHL: Follicular lymphoma (FL)
ublituximab: NHL: Diffuse large B-cell lymphoma (DLBCL)
ublituximab: Multiple sclerosis (MS)
LIST OF FIGURES
Figure 1: The authors drug assessment summary of ublituximab for CLL
Figure 2: Ublituximab sales for CLL in the US, 2017–26
Figure 3: Ublituximab for follicular lymphoma – SWOT analysis
Figure 4: The authors drug assessment summary of ublituximab for follicular lymphoma
Figure 5: Ublituximab sales for follicular lymphoma across the US and five major EU markets, by country, 2017–26
Figure 6: Ublituximab for diffuse large B-cell lymphoma – SWOT analysis
Figure 7: The authors drug assessment summary for ublituximab in diffuse large B-cell lymphoma
Figure 8: Ublituximab sales for diffuse large B-cell lymphoma across the US and five major EU markets, by country, 2017–26
Figure 9: Ublituximab for multiple sclerosis – SWOT analysis
Figure 10: The authors drug assessment summary of ublituximab for multiple sclerosis
LIST OF TABLES
Table 1: Ublituximab drug profile
Table 2: Trials of ublituximab for CLL
Table 3: Ublituximab for CLL – SWOT analysis
Table 4: Ublituximab drug profile
Table 5: Ublituximab ongoing pivotal trial in follicular lymphoma
Table 6: Ublituximab sales for follicular lymphoma across the US and five major EU markets, by country ($m), 2017–26
Table 7: Ublituximab drug profile
Table 8: Ublituximab ongoing pivotal trial in diffuse large B-cell lymphoma
Table 9: Ublituximab sales for diffuse large B-cell lymphoma across the US and five major EU markets, by country ($m), 2017–26
Table 10: Ublituximab drug profile
Table 11: Ublituximab Phase III trials in multiple sclerosis
