FDA/CDC

FDA approves ibrutinib with rituximab in Waldenström’s macroglobulinemia


 

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.

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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.

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