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Imbruvica—next big drug in B-cell cancer—approved by FDA

Nature Biotechnology volume 32, pages 113–114 (2014)Cite this article

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Imbruvica is a small molecule designed to block BTK, a tyrosine kinase involved in normal B-cell maturation, and in B-cell malignancies.

Imbruvica's accelerated approval for MCL was based on a single-arm trial with 111 patients, 66% of whom had their cancer shrink or disappear after treatment. Imbruvica is also awaiting approval, expected in February, in chronic lymphocytic leukemia (CLL), the most common adult leukemia. Anticipation over Imbruvica is mounting, particularly following the announcement in January that the first phase 3 RESONATE study, a head-to-head comparison with Genmab's and GlaxoSmithKline's anti-CD20 monoclonal antibody Arzerra (ofatumumab) in relapsed and refractory disease, was stopped early because primary and key secondary endpoints were met.

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  1. Freehold, New Jersey

    Malini Guha

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  1. Malini Guha
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Guha, M. Imbruvica—next big drug in B-cell cancer—approved by FDA. Nat Biotechnol 32, 113–114 (2014). https://doi.org/10.1038/nbt0214-113

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