The Janssen Pharmaceutical Companies of Johnson & Johnson announced that Health Canada has approved IMBRUVICA (ibrutinib) in combination with rituximab for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). Today's milestone marks the tenth Health Canada approval for IMBRUVICA across five disease areas and is the fifth approval for IMBRUVICA in CLL. This latest approval is based on the Phase 3 ECOG1912 study (also referred to as E1912) that demonstrated newly diagnosed patients age 70 or younger (median age of 58) treated with IMBRUVICA plus rituximab had significantly improved progression-free survival (PFS) compared to patients treated with fludarabine, cyclophosphamide and rituximab (FCR). The risk of disease progression or death was reduced by 66% in the IMBRUVICA arm compared with FCR, with a median follow-up time of 37 months. This approval was granted under a modified version of the newly established Project Orbis, an initiative of the FDA Oncology Center of Excellence, which provides a framework for submission and review of oncology medicine applications among international regulatory agencies. This initiative gives international regulators the ability to provide patients with cancer earlier access to important medicines. The ECOG1912 Study: The randomized, multi-centre, open-label, controlled Phase 3 E1912 study was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health in the United States. The study evaluated 529 previously untreated CLL patients ages 70 years or younger (median age of 58) who were randomly assigned to receive IMBRUVICA plus rituximab (n=354) or the chemoimmunotherapy FCR (n=175) and the primary endpoint was PFS as assessed by an independent review committee, according to the International Workshop on CLL. With a median follow-up time on study of 37 months, a PFS benefit was observed for the IMBRUVICA plus rituximab arm as compared to the FCR treatment arm (hazard ratio [HR], 0.34; 95% confidence interval [CI], 0.22-0.52; p<0.0001). With a median follow-up time of 49 months, median overall survival was not reached with a total of 23 deaths: 11 (3%) in the IMBRUVICA plus rituximab arm and 12 (7%) in the FCR treatment arm. The most commonly occurring adverse reactions in studies of CLL patients treated with IMBRUVICA (=20%) were neutropenia, diarrhea, fatigue, musculoskeletal pain, rash, thrombocytopenia, anemia, bruising, nausea, hemorrhage, cough, pyrexia, arthralgia, headache, upper respiratory tract infection and hypertension. Chronic Lymphocytic Leukemia: CLL is a cancer that begins in blood stem cells, starting in abnormal lymphoid stem cells. It usually develops slowly over the course of months or years. In 95% of cases, the abnormal lymphoid stem cells develop into cancerous, or malignant, B lymphocytes. CLL is one of the most common types of leukemia in adults. Over 2,200 people in Canada are diagnosed with CLL each year. IMBRUVICA contains the medicinal ingredient ibrutinib which is a targeted inhibitor of Bruton's tyrosine kinase (BTK), and it is the only once-daily BTK inhibitor in Canada. Ibrutinib blocks BTK activity, inhibiting cancer cell survival and spread. IMBRUVICA was first approved in Canada in 2014. It is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL), including those with 17p deletion; or adult patients with CLL who have received at least one prior therapy, including those with 17p deletion. It is indicated in combination with bendamustine and rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and in combination with obinutuzumab for treatment-naïve adult patients with CLL. It is now also indicated in combination with rituximab for the treatment of adult patients with previously untreated CLL. For adult patients with Waldenström's macroglobulinemia (WM), IMBRUVICA is indicated as a single agent or in combination with rituximab. Other indications are for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL); patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy; and for patients with steroid dependent or refractory chronic graft-versus-host disease (cGVHD).