TG THERAPEUTICS, INC — Briumvi FDA Review (BLA761238, ORIG 1, 2022)
TG THERAPEUTICS, INC · 2022 · FDA Review (openFDA) · company profile →
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This clinical review recommends approval of Ublituximab-xiiy (Briumvi) for relapsing forms of multiple sclerosis (MS) in adults. Two pivotal Phase 3 trials (TG1101-RMS301 and TG1101-RMS302) demonstrated Briumvi's superior efficacy over teriflunomide in reducing annualized relapse rates and MRI lesions. The proposed dosing is an initial 150mg IV, followed by 450mg IV two weeks later, then 450mg IV every six months. Safety data indicates Briumvi is an immune suppressant, with infections (including fatal cases), cytopenias, and infusion-related reactions being key concerns. While efficacy was clear, no significant difference in confirmed disability progression was observed. The safety profile is generally consistent with other anti-CD20 therapies, but higher rates of serious infections and infusion-related reactions were noted. Financial disclosures confirmed no significant conflicts of interest among investigators.
Key findings — cited to the page
| IRRs with 4th infusion (Week 48) in ublituximab-xiiy | 6.6 % | · p.201 |
| Number of SAEs rated as CTCAE Grade 2 in Study TG1101-RMS301 | 19 | Study TG1101-RMS301 · p.107 |
| IRRs in teriflunomide (pooled Study TG1101-RMS301 or TG1101-RMS302) | 12.2 % | · p.201 |
| IRRs with 1st infusion (Week 0) in ublituximab-xiiy | 43.3 % | · p.201 |
| IRRs with 5th infusion (Week 96) in ublituximab-xiiy | 4.8 % | · p.201 |
| Number of SAEs rated as CTCAE Grade 1 in Study TG1101-RMS301 | 6 | Study TG1101-RMS301 · p.107 |
| CTCAE Grade 3 or higher IRRs in ublituximab-xiiy | 2.8 % | · p.201 |
| IRRs in ublituximab-xiiy (pooled Study TG1101-RMS301 or TG1101-RMS302) | 47.7 % | · p.201 |
| IRRs with 2nd infusion (Week 2) in ublituximab-xiiy | 9.4 % | · p.201 |
| CTCAE Grade 3 or higher IRRs in teriflunomide | 0.2 % | · p.201 |
| IRRs with 3rd infusion (Week 24) in ublituximab-xiiy | 7.9 % | · p.201 |
| Number of SAEs rated as CTCAE Grade 1 in Study TG1101-RMS302 | 8 | Study TG1101-RMS302 · p.107 |
Source: TG THERAPEUTICS, INC ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →