IMBRUVICA® has successfully been studied and received FDA approval as a monotherapy in WM

The efficacy of IMBRUVICA® as a monotherapy for previously treated WM was evaluated in 2 single-arm trials1

  • The iNNOVATE™ open-label substudy arm C included 31 patients with previously treated WM who were refractory to their last rituximab-containing regimen (ie, relapse, after <12 months or failure to achieve at least a minor response). Response rate was a secondary endpoint1-3
  • Study 1118 was an open-label, multicenter, single-arm trial of 63 previously treated patients with a primary endpoint of overall response rate1,2

IMBRUVICA® Monotherapy1

Response rates across 2 studies


CR=complete response, FDA=US Food and Drug Administration, HR=hazard ratio, PR=partial response, RR=response rate, VGPR=very good partial response, WM=Waldenström's macroglobulinemia.


References: 1IMBRUVICA® (ibrutinib) Prescribing Information. 2Data on file.  3Dimopoulos MA, Trotman J, Tedeshi A, et al. Ibrutinib for patients with rituximab-refractory Waldenström’s macroglobulinemia (iNNOVATE): an open-label substudy of an international, multicentre, phase 3 trial. Lancet Oncol. 2017;18(2):241-250. 4Trotman J, Buske C, Tedeschi A, et al. Single-agent ibrutinib for rituximab-refractory Waldenström macroglobulinemia: final analysis of the substudy of the phase III Innovate™ trial. Clin Cancer Res. 2021;27(21):5793-5800. doi:10.1158/1078-0432.CCR-21-1497