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    DRUG:

    Ruxience (rituximab-pvvr)

    i
    Other names: PF-05280586, PF 05280586
    Company:
    Pfizer
    Drug class:
    CD20 inhibitor
    Related drugs:
    6ms
    DanNORMS: Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis (clinicaltrials.gov)
    P3, N=600, Active, not recruiting, Rigshospitalet, Denmark | Recruiting --> Active, not recruiting | Trial completion date: Dec 2028 --> May 2028 | Trial primary completion date: Dec 2025 --> May 2026
    Enrollment closed • Trial completion date • Trial primary completion date • Head-to-Head
    |
    FCER1G (Fc Fragment Of IgE Receptor Ig) • NEFL (Neurofilament Light Chain)
    |
    Ruxience (rituximab-pvvr) • Ocrevus (ocrelizumab) • methylprednisolone oral
    1year
    Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes (clinicaltrials.gov)
    P2, N=74, Recruiting, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Suspended --> Recruiting | N=36 --> 74 | Trial completion date: Apr 2027 --> Oct 2029 | Trial primary completion date: Apr 2026 --> Oct 2027
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    Rituxan (rituximab) • Ruxience (rituximab-pvvr)
    1year
    DanNORMS: Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis (clinicaltrials.gov)
    P3, N=594, Recruiting, Rigshospitalet, Denmark | Trial completion date: Apr 2028 --> Dec 2028 | Trial primary completion date: Apr 2025 --> Dec 2025
    Trial completion date • Trial primary completion date • Head-to-Head
    |
    NEFL (Neurofilament Light Chain)
    |
    Ruxience (rituximab-pvvr) • Ocrevus (ocrelizumab)
    over1year
    19-C-0042: Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Jun 2024 --> Jul 2023
    Trial primary completion date
    |
    Rituxan (rituximab) • Ruxience (rituximab-pvvr) • Lumoxiti (moxetumomab pasudotox)
    over1year
    Moxetumomab-Rituximab to Eliminate Minimal Residual Disease in Hairy Cell Leukemia (PEGS 2023)
    Complete remissions in hairy cell leukemia (HCL) with anti-CD22 recombinant immunotoxin Moxetumomab Pasudotox (Moxe) are more durable if minimal residual disease (MRD) negative, but anti-drug antibodies (ADA) can limit the effectiveness of the consolidation cycles needed to eliminate MRD. To prevent ADA, Rituximab or Ruxience was added to Moxe (MoxeR) and 9 (64%) of 14 evaluable patients so far achieved MRD-free CR. ADA was less frequent than Moxe alone historically.
    Minimal residual disease
    |
    Rituxan (rituximab) • Ruxience (rituximab-pvvr) • Lumoxiti (moxetumomab pasudotox)
    2years
    Post-Transplant Lymphoproliferative Disorder Presenting as Iron Deficiency Anemia: A Case Report (ACG 2022)
    He had remained on chronic immunosuppression (Mycophenolate, tacrolimus, prednisone)...He was treated with weekly Rituximab/Ruxience biosimilar followed by the CHOP chemotherapy regimen...1A) ulcerated lesion with nodular mucosa in the terminal ileum (Fig. 1B) histology slide showing monomorphic PTLD Diffuse Large B Cell Lymphoma (DLBCL)
    Clinical • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    TNFRSF8 expression • MYC translocation
    |
    Rituxan (rituximab) • prednisone • Ruxience (rituximab-pvvr)