The medication Imbruvica® (ibrutinib) from AbbVie first gained FDA approval in 2013 for treating mantle cell lymphoma, then in 2014 the approval was expanded to include chronic lymphocytic leukemia. The next year, 2015, Waldenstrom’s macroglobulinemia was added to the FDA approvals for this medication. Now, in 2017, Imbruvica has been granted an accelerated approval as a treatment for another form of lymphoma: marginal zone lymphoma (MZL).
If the approval is granted, this medication will be used in patients with MZL who previously tried one or more prior bouts of anti-CD20-based therapy. The accelerated approval is based on results from a new open-label study presented at the 2016 American Society of Hematology Annual Meeting.
Patients with MZL taking Imbruvica showed an objective response rate of 46%, with a median progression-free survival of 14.2 months. Marginal zone lymphoma is a rare, but very serious, type of blood cancer. Currently, there are not satisfactory treatment options for MZL. If approved, Imbruvica will offer additional hope for patients facing this difficult diagnosis.
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.