The U.S. Food and Drug Administration (FDA) approved ibrutinib, in combination with rituximab, for the treatment of adult patients with Waldenström macroglobulinemia (WM). In 2015, the agency approved ibrutinib as a single agent for this indication.
The most recent approval decision was based on results from the phase III iNNOVATE trial, which included 150 patients with treatment-naïve or relapsed or refractory symptomatic WM. Patients received rituximab, in combination with either ibrutinib or a placebo, weekly for four consecutive weeks, followed by a second four-week course after three months.
In the group that received ibrutinib plus rituximab, the rate of 30-month progression-free survival was 82 percent, compared with 28 percent in the placebo group (p<0.0001). Ibrutinib plus rituximab also resulted in a higher rate of major response than rituximab treatment (p<0.001).
Adverse events (AEs) that were more common in the ibrutinib combination arm than in the rituximab-alone arm included atrial fibrillation and hypertension. AEs occurring more frequently in the rituximab-alone arm included immunoglobin M flare and infusion-related reactions.
Source: Janssen press release, August 27, 2018.