The approval marks the first non-chemotherapy combination regimen for the treatment of patients with chronic lymphocytic leukemia (CLL).
The FDA has approved ibrutinib (Imbruvica) in combination with obinutuzumab for treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Ibrutinib is a first-in-class, once-daily inhibitor of Bruton’s tyrosine kinase approved in 2016 as a single-agent, chemotherapy-regimen for patients with CLL. This new approval expands ibrutinib’s label to now include the treatment in frontline CLL/SLL beyond monotherapy and marks the first non-chemotherapy combination regimen for the treatment of these patients.
The approval follows positive data coming from the iLLUMINATE study, which demonstrated that at a median follow-up of 31 months, the treatment regimen significantly improved progression-free survival compared with chlorambucil plus obinutuzumab, with a 77% reduction in risk of progression or death. Results also showed that among patients with high-risk disease, there was an 85% reduction in risk of progression or death.
The most common adverse events included neutropenia (48%), thrombocytopenia (36%), rash (36%), diarrhea (34%), musculoskeletal pain (33%), and bruising (32%).
“In just a few years, Imbruvica has become an important treatment for CLL. Imbruvica as a single agent—and now as a combination with obinutuzumab—provides patients with CLL with an alternative to frontline treatment with chemoimmunotherapy,” said Carol Moreno, MD, PhD, consultant hematologist, Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, and lead investigator of the iLLUMINATE study, in a statement.
The recommended dose of ibrutinib is 420 mg orally once daily until progression of disease or unacceptable toxicity. This marks the 10th approval for the treatment.
According to Janssen, the FDA also updated ibrutinib’s label to include additional long-term data supporting its use as monotherapy in CLL/SLL based on 5 years of follow-up data coming from the phase 3 RESONATE and RESONATE-2 trials. Warning and precautions of the treatment include hemorrhage, infections, cytopenias, and hypertension.
Results of the iLLUMINATE study, as well as other studies showing benefit of ibrutinib alone or in combination were presented at the 60th American Society of Hematology Annual Meeting in December 2018. During the meeting, we sat down with Mark Wildgust, PhD, vice president, global medical affairs, oncology at Janssen. Watch below: