Evidence-Based Oncology
February 2021
Volume 27
Issue 2
Pages: SP59

FDA Updates Ibrutinib Label With 5-Year Data in Waldenström Macroglobulinemia


The newly approved expanded label includes data from the final analysis of the phase 3 iNNOVATE study of ibrutinib plus rituximab vs rituximab alone.

The FDA updated prescribing information for ibrutinib (Imbruvica), a Bruton tyrosine kinase (BTK) inhibitor approved to treat Waldenström macroglobulinemia (WM), to include 5 years of efficacy data, AbbVie announced in a press release.1

The approval of updated prescribing information is based on positive safety and efficacy data from the final analysis of the phase 3 iNNOVATE study, which were presented at the 2020 American Society of Hematology (ASH) meeting. At an overall follow-up of 5 years, combination ibrutinib and rituximab therapy led to significantly longer progression-free survival (PFS) and was more effective than rituximab monotherapy in both previously treated and treatment-naïve patients.2

The iNNOVATE trial randomized 150 patients to receive either ibrutinib and rituximab or rituximab monotherapy. Patients in the ibrutinib arm of the trial had a 75% lower risk of disease progression and death than those in the rituximab monotherapy group (HR, 0.25; 95% CI, 0.15-0.42; P < .0001).

“We’re encouraged by this latest recognition from the FDA as it underscores our commitment to supporting those impacted by Waldenström’s macroglobulinemia, a rare and incurable form of non-Hodgkin lymphoma,” Danelle James, MD, MAS, Imbruvica global development lead, said in a statement. “Imbruvica is the only FDA-approved treatment for these patients and now includes more than 5 years of safety and efficacy data to help provide better understanding of how to treat this rare blood cancer.”

Ibrutinib is currently approved for patients with several types of blood cancer both as a monotherapy and in combination with rituximab, and the data presented at ASH are currently the longest available for any BTK inhibitor in WM.

“The long-term results from the phase 3 iNNOVATE study provide clinicians even more evidence that patients with WM can benefit from treatment with an ibrutinib-based regimen and maintain prolonged progression-free survival,” said principal investigator Meletios A. Dimopoulos, MD, professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine in Athens, Greece.


1. Imbruvica (ibrutinib) US prescribing information updated to include long-term data for Waldenström’s macroglobulinemia (WM). News release. AbbVie. December 23, 2020. Accessed December 23, 2020.

2. Buske C, Tedeschi A, Trotman J, et al. Five-year follow-up of ibrutinib plus rituximab vs placebo plus rituximab for Waldenstrom’s macroglobulinemia: final analysis from the randomized phase 3 iNNOVATE study. Paper presented at: American Society of Hematology Annual Meeting; December 5-8, 2020. Abstract 336.

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