The U.S. Food and Drug Administration (FDA) approved ibrutinib, in combination with rituximab, for the treatment of adult patients with Waldenström macroglobulinemia (WM).
The agency’s decision is based on findings from the phase III iNNOVATE trial and follows the agency’s 2015 decision to approve ibrutinib as a single agent for this indication.
The iNNOVATE trial 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.