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Imbruvica U.S. prescribing information updated to include long-term data for Waldenström's Macroglobulinemia. AbbVie

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Published:31st Dec 2020
AbbVie announced that the 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 III 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. 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. 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. The Imbruvica Prescribing Information now includes final analysis data, with an overall follow-up of 63 months, from the Phase III 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<0.0001). results from the final analysis of the study were recently featured as an oral presentation at the 2020 american society of hematology (ash) annual meeting (abstract #336).>
Condition: Waldenstrom's Macroglobulinemia
Type: drug

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