Ibrutinib, a once-a-day drug that is administered orally, inhibits the first-in-class Bruton’s tyrosine kinase (BTK) that sends crucial signals to B cells to mature and produce antibodies, said Janssen.
The expanded approval was based on data from the phase 3 E1912 study, which demonstrated 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 ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) designed and carried out the study in the US. It was sponsored by the National Cancer Institute (NCI), which is part of the US National Institutes of Health.
The phase 3 E1912 trial assessed 529 previously untreated patients with CLL aged 70 years or younger, and they have been randomised to secure six cycles of ibrutinib plus rituximab.
In April this year, the company secured approval from the US Food and Drug Administration for Imbruvica plus rituximab for the same indication.
Janssen Research & Development oncology, clinical development and global medical affairs vice president Dr Craig Tendler said: “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.
“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.”
In June this year, Janssen Pharmaceutical secured EC approval for the subcutaneous formulation of Darzalex (daratumumab) for the treatment of multiple myeloma in adult patients.