- Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS) versus rituximab alone in adults with WM

- IMBRUVICA is the first and only FDA-approved treatment for adults with WM and has been used to treat more than 200,000 patients worldwide across approved indications

NORTH CHICAGO, Ill., Dec. 23, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) approved the update of the IMBRUVICA® (ibrutinib) Prescribing Information to include efficacy and safety data for the combination of IMBRUVICA with rituximab for the treatment of Waldenström's macroglobulinemia (WM), based on the final analysis of the Phase 3 iNNOVATE study. First approved in 2013, IMBRUVICA is currently available to patients with several types of blood cancer, as well as chronic graft-versus-host disease. It was approved as a monotherapy for WM in 2015 and as a combination therapy with rituximab in 2018 based on the iNNOVATE primary analysis.

"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's lymphoma," said Danelle James, M.D., M.A.S., IMBRUVICA Global Development Lead, Pharmacyclics LLC, an AbbVie company. "IMBRUVICA is the only FDA-approved treatment for these patients and now includes more than five years of safety and efficacy data to help provide better understanding of how to treat this rare blood cancer."

As of today, IMBRUVICA is the only Bruton's tyrosine kinase (BTK) inhibitor approved to treat WM. WM typically affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may also be affected. In the U.S., there are approximately 2,800 new cases of WM each year.1 The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends IMBRUVICA, with or without rituximab, as the only Category 1 Preferred regimen for patients with previously untreated or previously treated WM.2

"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 Dr. Meletios A. Dimopoulos, Professor and Chairman of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator.

The IMBRUVICA Prescribing Information now includes final analysis data, with an overall follow-up of 63 months, from the Phase 3 iNNOVATE clinical trial. With additional follow-up since the primary analysis, the combination of IMBRUVICA plus rituximab continued to demonstrate prolonged progression-free survival (PFS) in WM patients compared to rituximab monotherapy. Patients treated in the IMBRUVICA arm experienced a 75 percent reduction in risk of disease progression or death compared to rituximab monotherapy (hazard ratio [HR] 0.25; 95% confidence interval [CI]: 0.15-0.42; p