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www.fdanews.com/articles/208123-imbruvica-reduces-disease-progression-death-in-mantle-cell-lymphoma-trial

Imbruvica Reduces Disease Progression, Death in Mantle Cell Lymphoma Trial

June 7, 2022

Janssen’s blockbuster cancer drug Imbruvica (ibrutinib) plus bendamustine-rituximab (BR) and rituximab reduced the risk of disease progression or death by 25 percent in patients aged 65 years or older with newly diagnosed mantle cell lymphoma (MCL), compared to patients who received placebo plus BR and rituximab.

The new data are from the company’s phase 3 SHINE study in patients with MCL, an aggressive and rare type of non-Hodgkin lymphoma that is difficult to treat. The study enrolled 523 patients age 65 and up with newly diagnosed MCL.

Imbruvica was approved by the FDA in November 2013, and it is currently indicated for adult patients in six disease areas, including five blood cancers.

The trial results, presented at the 2022 American Society of Clinical Oncology (ASCO) annual meeting, June 4-7, are being published in The New England Journal of Medicine.

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