Janssen's Imbruvica secures label expansion in Europe in chronic lymphocytic leukaemia

The European Commission (EC) has moved to expand the existing approval of Janssen’s Imbruvica (ibrutinib) in chronic lymphocytic leukaemia (CLL) to include previously untreated adult patients when used in combination with rituximab.

Phase 3 data supplied in support of the application were drawn from 529 previously untreated patients aged 70 years or younger, who were randomised to receive either a standard of care chemo-immunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR), or six cycles of Imbruvica and rituximab followed by Imbruvica until disease progression or unacceptable toxicity is reached.

Patients receiving the Imbruvica/rituximab combo demonstrated a progression-free survival rate of 88% at a median follow-up of 37 months, compared to 75% with the FCR regimen. An advantage in overall survival was also observed in patients receiving the Imbruvica/rituximab combo.

“Ibrutinib is the most comprehensively studied Bruton’s tyrosine kinase (BTK) inhibitor with the longest follow-up across eight positive Phase 3 trials in CLL to date, and is recognised as an important advancement in treatment for patients with CLL,” said Dr Craig Tendler, Janssen’s Vice President, Clinical Development and Global Medical Affairs, Oncology. “This latest milestone highlights our commitment to studying the full potential of ibrutinib and in developing regimens which can transform what a CLL diagnosis means for patients going forward.”

The ECOG-ACRIN Cancer Research Group was responsible for designing and conducting the study, which was sponsored by the National Cancer Institute.

Matt Fellows