The Food and Drug Administration has approved ibrutinib (Imbruvica) for use in combination with rituximab to treat adults with Waldenström’s macroglobulinemia (WM).
Ibrutinib was approved for use as a single agent in adults with WM in January 2015.
The latest approval was supported by the phase 3 iNNOVATE trial, in which researchers compared ibrutinib plus rituximab to rituximab alone in patients with previously untreated or relapsed/refractory WM.
Results from iNNOVATE were presented at the 2018 annual meeting of the American Society of Clinical Oncology and simultaneously published in the New England Journal of Medicine (2018;378:2399-2410).
The 30-month progression-free survival rates were 82% in the ibrutinib arm and 28% in the placebo arm. The median progression-free survival was not reached in the ibrutinib arm and was 20.3 months in the placebo arm (hazard ratio, 0.20; P less than .0001).
The 30-month overall survival rates were 94% in the ibrutinib arm and 92% in the placebo arm.
Grade 3 or higher treatment-emergent adverse events (AEs) occurred in 60% of patients in the ibrutinib arm and 61% in the placebo arm. Serious AEs occurred in 43% and 33%, respectively. There were no fatal AEs in the ibrutinib arm and three in the rituximab arm.
Ibrutinib is jointly developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech.