The FDA approved ibrutinib in combination with obinutuzumab for the treatment of patients with treatment-naive chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), according to the manufacturer.
This is the first approval of a non-chemotherapy combination for frontline treatment of CLL/SLL patients.
“In just a few years, Imbruvica has become an important treatment for chronic lymphocytic leukemia. Imbruvica as a single agent – and now as a combination with obinutuzumab – provides patients with CLL with an alternative to frontline treatment with chemoimmunotherapy,” Carol Moreno, MD, PhD, of the Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, in Spain, said in a press release.
Leukemia cells. Source: Getty
The FDA based this approval on results from the phase 3 iLLUMINATE study, which found that ibrutinib plus obinutuzumab improved progression-free survival as assessed by a Independent Review Committee compared with chlorambucil plus obinutuzumab (HR = 0.23; 95% CI, 0.15-0.37). Researchers observed a 77% reduction in risk of progression or death among patients treated with ibrutinib combination.
Patients with high-risk disease had a 85% reduction in risk of progression or death when treated with ibrutinib combination compared with chlorambucil combination (HR = 0.15; 95% CI, 0.09-0.27).
The overall response rate was 89% in the treatment arm compared with 73% in the control arm.
"This label update builds upon the established efficacy and safety of IMBRUVICA in the frontline treatment of patients with CLL/SLL, as a monotherapy or in combination with other treatments," Craig Tendler, MD, vice president, clinical development and global medical affairs at Janssen, said in the release.
The most common adverse events observed among patients treated with ibrutinib combination in the iLLUMINATE trial included neutropenia (48%), thrombocytopenia (36%), rash (36%), diarrhea (34%), musculoskeletal pain (33%), bruising (32%), cough (27%), infusion related reaction (25%), hemorrhage (25%) and arthralgia (22%).