In April 2023, AbbVie voluntarily recalled ibrutinib (Imbruvica) for the treatment of mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) in the USA.1 This withdrawal marks the end of, for now, 10 years of the product’s marketing and sales for this indication. Here, we describe the approval history and regulatory implications of ibrutinib’s withdrawal from the US market.
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Lipfert et al. (2024) studied this question.
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