EU approves Imbruvica plus Rituxan for Waldenstr�m's macroglobulinemia

Janssen Pharma has announced the European Commission approval of Imbruvica (ibrutinib) for the treatment of adult patients with Waldenström's macroglobulinemia in combination with Rituxan (rituximab). The approval follows the Positive Opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use on 28 June 2019. The approval was based on the Phase III iNNOVATE (PCYC-1127) study.

an An interim analysis of the Phase III iNNOVATE (PCYC-1127) study evaluating ibrutinib plus rituximab in previously untreated and relapsed/refractory patients with Waldenström's macroglobulinemia found that at a median follow up of 26.5 months, the study successfully met its primary endpoint, demonstrating a significant improvement in progression-free survival (PFS) with ibrutinib plus rituximab compared to rituximab alone (30 month PFS rates were 82 percent versus 28 percent, respectively).

Patients taking ibrutinib plus rituximab also experienced an 80 percent reduction in relative risk of disease progression or death than those only treated with rituximab. Additionally, the data found that the combination with ibrutinib provided reductions in infusion reactions associated with rituximab and immunoglobin M (IgM) flare.