The FDA has approved AbbVie/Johnson & Johnson's Imbruvica (ibrutinib) in combination with Roche's Gazyva in treatment-naïve patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma (CLL/SLL).
The approval marks the first authorisation of a non-chemotherapy combination regimen in these indications.
AbbVie and Johnson & Johnson's Janssen Pharmaceutical have announced the approval based on results from the Phase III iLLUMINATE study, which consisted of 229 patients, with results showing that after a median follow-up of 31 months, Imbruvica plus Gazyva (obinutuzumab) demonstrated a significant improvement in progression-free survival compared with chlorambucil and Gazyva, with a 77% reduction in the risk of progression or death.
"In just a few years, Imbruvica has become an important treatment for chronic lymphocytic leukemia,” lead iLLUMINATE study author Carol Moreno, told the media.
“Imbruvica as a single agent - and now as a combination with obinutuzumab - provides patients with CLL with an alternative to frontline treatment with chemoimmunotherapy.”
AbbVie and Janssen noted that the FDA also updated Imbruvica's label to include additional long-term efficacy data supporting its use as a monotherapy in CLL/SLL, with approximately five years of follow-up from the Phase III RESONATE and RESONATE-2 studies.