Danelle James, M.D., M.A.S. of Pharmacyclics, an AbbVie company discusses IMBRUVICA® (ibrutinib) U.S. Prescribing Information Updated to Include Long-Term Data for Waldenström’s Macroglobulinemia (WM).
Today, AbbVie reported that the U.S. The update of the IMBRUVICA® (ibrutinib) Prescription Details has been approved by the Food and Drug Administration (FDA) to provide efficacy and safety data for the combination of IMBRUVICA with rituximab for the treatment of Waldenström’s macroglobulinemia (WM) based on the final review of Phase 3 iNNOVATE trial. IMBRUVICA is currently available for patients with many forms of blood cancer, as well as chronic graft-versus-host disease, and was first approved in 2013. On the basis of the iNNOVATE primary study, it was approved as a monotherapy for WM in 2015 and as a combination therapy with rituximab in 2018.
As of today, IMBRUVICA is the only licensed inhibitor of Bruton’s tyrosine kinase (BTK) to treat WM. WM usually affects older adults and is located mainly in the bone marrow, although it can also affect lymph nodes and the spleen. There are approximately 2,800 new WM cases per year in the United States.1 The National Comprehensive Cancer Network® (NCCN®), a non-profit partnership of 28 leading cancer centers committed to patient care, study, and education, recommends IMBRUVICA as the only Category 1 recommended regimen for patients with previously untreated or previously treated WM, with or without rituximab.
The IMBRUVICA Prescription Information now provides final review results from the Phase 3 iNNOVATE clinical trial, with an overall follow-up of 63 months. The combination of IMBRUVICA plus rituximab continued to show extended progression-free survival (PFS) in WM patients relative to rituximab monotherapy, with additional follow-up from the primary study. Compared to rituximab monotherapy, patients treated in the IMBRUVICA arm observed a 75 percent reduction in risk of disease development or death (hazard ratio [HR] 0.25; 95 percent confidence interval [CI]: 0.15-0.42; p<0.0001). Results from the final research review were recently presented as an oral presentation at the Annual Meeting of the 2020 American Society of Hematology (ASH) (Abstract #336).
In the primary review of the iNNOVATE study, swelling, muscle pain, bleeding issues, diarrhea, rash, knee pain, nausea and high blood pressure were the most common side effects (~20 percent) in patients treated with IMBRUVICA plus rituximab.