U.S. prescribing information for ibrutinib in Waldenström's macroglobulinemia to be reviewed and potentially updated by the FDA following long-term data

On June 23, 2020, it was announced that the U.S. Food and Drug Administration (FDA) will review a supplemental new drug application for ibrutinib in combination with rituximab for the treatment of Waldenström's macroglobulinemia (WM). This application requests to update the ibrutinib U.S. prescribing information based on the long-term analysis (more than 5 years of data) from the phase III iNNOVATE trial (NCT02165397).¹

Ibrutinib is an oral, first-in-class BTK inhibitor (BTKi). The iNNOVATE trial evaluated ibrutinib combined with rituximab vs rituximab alone in 150 patients with relapsed/refractory and treatment-naïve WM. The trial met its primary endpoint, demonstrating a significant improvement in progression-free survival with the combination of ibrutinib plus rituximab vs rituximab plus placebo.²

In 2015, ibrutinib was first approved by the FDA as a single-agent therapy for all lines of WM treatment. Then, in 2018, the ibrutinib plus rituximab combination was approved for the treatment of WM.¹ Currently, ibrutinib is the only BTKi approved for the treatment of WM, and its combination with rituximab offers a chemotherapy-free treatment option.

The results from the long-term analysis of the iNNOVATE trial are awaited and are expected to be presented at a future medical congress. In the meantime, click here to read the initial results from the phase III trial of ibrutinib plus rituximab vs rituximab alone in Waldenström's macroglobulinemia, presented at the 23rd Congress of the European Hematology Association (EHA). Judith Trotman discussed the key findings from the iNNOVATE study at EHA 2018; click here to watch it.

The full prescribing information can be found here.