EU approves variation to MAA for Imbruvica plus Rituxan in chronic lymphocytic leukaemia.- Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has approved a variation to the marketing authorisation for Imbruvica (ibrutinib), extending the approved indication in chronic lymphocytic leukaemia (CLL) to include combination with rituximab for previously untreated adult patients. The decision is based on data from the Phase III E1912 study that showed previously untreated patients aged 70 years or younger treated with ibrutinib plus rituximab lived longer without disease progression than those treated with the established chemo-immunotherapy regimen fludarabine, cyclophosphamide and rituximab (FCR). The study evaluated 529 previously untreated patients with CLL aged 70 years or younger (median age, 58 years) who were randomly assigned to receive six cycles of ibrutinib plus rituximab (IR) (n=354), followed by ibrutinib until disease progression or unacceptable toxicity, or six cycles of FCR (n=175). At a median follow-up of 37 months, patients treated with IR lived longer without disease progression, with a progression-free survival (PFS) rate of 88 percent, compared to 75 percent for patients treated with FCR (hazard ratio [HR] 0.34; 95% confidence interval [CI], 0.22-0.52; p<0.0001). the study also showed an overall survival (os) advantage for patients treated with the ir regimen. the primary study results were published previously in the new england journal of medicine, and with extended 48-month follow-up, as presented at the 2019 american society of hematology (ash) annual meeting, the initial treatment benefit is maintained.>