7 September 2020 - Patients who were new to chronic lymphocytic leukaemia treatment lived longer without disease progression with the Imbruvica based regimen compared to patients treated with a chemo-immunotherapy regimen.

Janssen announced today that the European Commission has approved a variation to the marketing authorisation for Imbruvica (ibrutinib), extending the approved indication in chronic lymphocytic leukaemia to include combination with rituximab for previously untreated adult patients. 

The decision is based on data from the Phase 3 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.

Read Janssen press release