AbbVie, Johnson & Johnson's Imbruvica gains FDA clearance as first non-chemotherapy combination regimen for first-line treatment of CLL

AbbVie and Johnson & Johnson's Janssen Pharmaceutical unit announced Monday that the FDA approved Imbruvica (ibrutinib) in combination with Roche's Gazyva (obinutuzumab) in treatment-naïve patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL). The companies noted that this is the first authorisation of a non-chemotherapy combination regimen in these indications.

The approval is based on results from the Phase III iLLUMINATE study, which showed that after a median follow-up of 31 months, Imbruvica plus Gazyva led to significant improvement in progression-free survival versus chlorambucil plus Gazyva, with a 77-percent reduction in the risk of progression or death. Data also showed that patients with high-risk disease who were treated with Imbruvica plus Gazyva experienced an 85-percent reduction in risk of progression or death.

AbbVie and Johnson & Johnson 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.

The companies are jointly developing and marketing Imbruvica, with AbbVie reporting last week that sales of the BTK inhibitor in the fourth quarter of 2018 rose 42 percent year-over-year to $1 billion. For related analysis, see Key takeaways from AbbVie's Q4 earnings and investor call.

For further analysis, see also ViewPoints: AbbVie continues its Imbruvica assault as Roche looks beyond Rituxan.

To read more Top Story articles, click here.