FDA Approves Ibrutinib for Rare Type of NHL

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to ibrutinib (Imbruvica) for the treatment of patients with relapsed/refractory marginal zone lymphoma who require systemic therapy and have received at least 1 prior anti-CD20-based therapy.¹

Approval in marginal zone lymphoma is based on findings from the multicenter, open-label, single-arm, phase 2 PCYC-1121 trial (ClinicalTrials.gov Identifier: NCT01980628), which assessed the efficacy and safety of ibrutinib in this patient population.

Among 63 patients with 3 subtypes of marginal zone lymphoma, 46% (95% CI, 33.4-59.1) achieved an overall response, including 3.2% who achieved a complete response and 42.9% who had partial response.

Median time to response was 4.5 months; the median duration of response was not reached.

The safety profile of ibrutinib in this study was consistent with previously reported safety data of ibrutinib in B-cell malignancies. The most frequently reported adverse events occurring in at least 20% of patients were thrombocytopenia, fatigue, anemia, diarrhea, bruising, musculoskeletal pain, hemorrhage, rash, nausea, peripheral edema, arthralgia, neutropenia, cough, dyspnea, and upper respiratory tract infection. The most common grade 3 to 4 adverse events were decreases in hemoglobin and neutrophils, as well as pneumonia.

Ibrutinib is also indicated for patients with mantle cell lymphoma who have received at least 1 prior therapy, chronic lymphocytic leukemia/small lymphocytic lymphoma with or without 17p deletion, and Waldenström macroglobulinemia.

Reference

1. U.S. FDA approves Imbruvica (ibrutinib) as first treatment specifically indicated for relapsed/refractory marginal zone lymphoma (MZL) – a rare type of non-Hodgkin’s lymphoma. Abbvie website. https://news.abbvie.com/news/us-fda-approves-imbruvica-ibrutinib-as-first-treatment-specifically-indicated-for-relapsedrefractory-marginal-zone-lymphoma-mzl–rare-type-non-hodgkins-lymphoma.htm. Published January 19, 2017. Accessed January 19, 2017.