13 August 2019 - Decision represents the fifth European approval in five years.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has approved variations to broaden the use of Imbruvica (ibrutinib) in two indications. This includes the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and the use of ibrutinib plus rituximab for the treatment of adult patients with Waldenström's macroglobulinemia (WM).
The approval follows the Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 28 June 2019.
The approval in CLL was based on results from the Phase 3 iLLUMINATE (PCYC-1130) study, published in The Lancet Oncology, which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with previously untreated CLL.
In WM, the decision was based on data from the Phase 3 iNNOVATE (PCYC-1127) study, published in the New England Journal of Medicine.