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    Association details:
    Biomarker:No biomarker
    Cancer:Chronic Lymphocytic Leukemia
    Drug:Imbruvica (ibrutinib) (BTK inhibitor) +
    Rituxan (rituximab) (CD20 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    PRNewswire
    Title:

    Health Canada Approves IMBRUVICA®* (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)

    Published date:
    01/13/2021
    Excerpt:
    The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    10/21/2014
    Excerpt:
    Imbruvica as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
    Secondary therapy:
    bendamustine
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    10/21/2014
    Excerpt:
    Imbruvica as a single agent or in combination with rituximab or obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    For CLL/SLL, IMBRUVICA can be administered as a single agent, in combination with rituximab or obinutuzumab, or in combination with bendamustine and rituximab (BR).
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Chronic lymphocytic leukemia/Small lymphocytic lymphoma…Other recommended regimens…Bendamustine, rituximab + ibrutinib (category 2B)
    Secondary therapy:
    bendamustine
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma:…CLL/SLL without del(17p)/TP53 mutation…FIRST-LINE THERAPY…Other recommended regimens…Ibrutinib + rituximab (category 2B)...
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Leuk Lymphoma
    Title:

    Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma

    Published date:
    08/06/2020
    Excerpt:
    We report final analysis outcomes from the phase 3 HELIOS study (NCT01611090). Patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma without deletion 17p (n = 578) were randomized 1:1 to 420 mg daily ibrutinib or placebo plus ≤6 cycles of bendamustine plus rituximab (BR), followed by ibrutinib or placebo alone. Median follow-up was 63.7 months. Median investigator-assessed progression-free survival was longer with ibrutinib plus BR (65.1 months) than placebo plus BR (14.3 months; hazard ratio [HR] 0.229 [95% confidence interval (CI) 0.183-0.286]; p < .0001).
    Secondary therapy:
    bendamustine
    DOI:
    10.1080/10428194.2020.1795159
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    N Engl J Med
    Title:

    Ibrutinib-Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia

    Excerpt:
    The results of the analysis of overall survival also favored ibrutinib-rituximab over chemoimmunotherapy (98.8% vs. 91.5% at 3 years; hazard ratio for death, 0.17; 95% CI, 0.05 to 0.54; P<0.001)...The ibrutinib-rituximab regimen resulted in progression-free survival and overall survival that were superior to those with a standard chemoimmunotherapy regimen among patients 70 years of age or younger with previously untreated CLL.
    DOI:
    10.1056/NEJMoa1817073
    Trial ID:
    ECOG-ACRIN E1912