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    Association details:
    Biomarker:CD20 positive
    Cancer:Follicular Lymphoma
    Drug:Ruxience (rituximab-pvvr) (CD20 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Therapeutic Goods Administration
    Published date:
    03/10/2021
    Excerpt:
    Australian prescription medicine decision summary...Ruxience (rituximab) was approved for the following therapeutic use...Non-Hodgkin's lymphoma...CD20 positive, previously untreated, Stage III/IV follicular, B-cell non-Hodgkin's lymphoma
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    05/26/2020
    Excerpt:
    RUXIENCE (rituximab-pvvr) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with...Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
    Secondary therapy:
    Chemotherapy
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    04/07/2020
    Excerpt:
    Ruxience is a medicine used in adults to treat the following blood cancers and inflammatory conditions...follicular lymphoma and diffuse large B cell non-Hodgkin’s lymphoma (two types of nonHodgkin’s lymphoma, a blood cancer)
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    RUXIENCE (rituximab-pvvr) is a CD20-directed cytolytic antibody indicated for the treatment of...Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    BioDrugs
    Title:

    A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera ®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)

    Published date:
    12/09/2019
    Excerpt:
    Subjects with CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL)...A total of 394 subjects were randomized: PF-05280586 (n = 196) or rituximab-EU (n = 198). ORR at week 26 was 75.5% (PF-05280586) versus 70.7% (rituximab-EU)...Rates of CR were 29.3% (PF-05280586) versus 31.0% (rituximab-EU). Estimated 1-year PFS rates were 78.2% (95% CI 70.2-84.2) and 83.0% (95% CI 75.0-88.6) for PF-05280586 and rituximab-EU, respectively.
    DOI:
    10.1007/s40259-019-00398-7
    Trial ID:
    REFLECTIONS B328-06t; 2014-000132-41
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)

    Excerpt:
    ...- Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma...
    Trial ID:
    REFLECTIONS B328-06t