European Union expands Imbruvica (ibrutinib) indications to include untreated chronic lymphocytic leukaemia patients

Approval based on RCT (n=529), which showed patients treated with 6 cycles of ibrutinib plus rituximab (then ibrutinib until disease progression) had a progression-free survival rate of 88% vs 75% for patients treated with fludarabine, cyclophosphamide and rituximab at 37 months