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FDA Approves Ibrutinib for Marginal Zone Lymphoma

Silas Inman @silasinman
Published: Thursday, Jan 19, 2017

Dr Ariela Noy

Ariela Noy, MD

The FDA has granted an accelerated approval to ibrutinib (Imbruvica) as a treatment for patients who require systemic therapy with marginal zone lymphoma (MZL) following at least one prior anti-CD20-based therapy, based on findings from a single-arm phase II study.

The accelerated approval for MZL is contingent upon findings from a larger confirmatory study. Ibrutinib has previously been approved by the FDA for the treatment of patients with mantle cell lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma, and Waldenström’s macroglobulinemia.
Noy A, de Vos S. Thieblemont C, et al. Single-Agent Ibrutinib Demonstrates Efficacy and Safety in Patients with Relapsed/Refractory Marginal Zone Lymphoma: A Multicenter, Open-Label, Phase 2 Study. Presented at: ASH 2016 Annual Meeting. Abstract 1213.

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