You are here

FDA Expands Imbruvica Label to Include Marginal-Zone Lymphoma

Other indications include CLL and macroglobulinemia

The FDA has approved ibrutinib (Imbruvica, Janssen Biotech/AbbVie) for the treatment of patients with relapsed/refractory marginal-zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti–CD20-based therapy. In the United States, ibrutinib now has five distinct indications: chronic lymphocytic leukemia, small lymphocytic lymphoma, Waldenström’s macroglobulinemia, previously treated mantle-cell lymphoma, and MZL.

MZL is a slow-growing B-cell lymphoma arising from lymphocytes at the edges of lymphoid tissue. It accounts for approximately 8% of all cases of non-Hodgkin’s lymphoma in adults, and the median age at diagnosis is 65 years.

The FDA’s decision was based on data from a phase 2, open-label, multicenter, single-arm study that evaluated the safety and efficacy of ibrutinib in MZL patients who required systemic therapy and had received at least one prior anti–CD20-based therapy. The efficacy analysis included 63 patients with the three subtypes of MZL: mucosa-associated lymphoid tissue (n = 32), nodal (n = 17), and splenic (n = 14).

The overall response rate (ORR) was 46%, as assessed by an independent review committee using the International Working Group criteria for malignant lymphoma, with efficacy observed across all three MZL subtypes. The median period to a response was 4.5 months (range, 2.3–16.4 months). In the study, 3.2% of patients had a complete response and 42.9% had a partial response. The median duration of responses was not reached.

The safety data from this study were consistent with the known safety profile of ibrutinib in B-cell malignancies. The most common adverse events included thrombocytopenia (49%), fatigue (44%), anemia (43%), diarrhea (43%), bruising (41%), musculoskeletal pain (40%), hemorrhage (30%), rash (29%), nausea (25%), peripheral edema and arthralgia (24% each), neutropenia (22%), cough (22%), dyspnea (21%), and upper respiratory tract infection (21%). The most common grade 3 or 4 adverse events included decreases in hemoglobin and neutrophils (13% each) and pneumonia (10%).

The new indication for ibrutinib was approved under accelerated approval based on the ORR, and continued approval may be contingent on the verification and description of clinical benefit in a confirmatory trial.

Source: AbbVie; January 19, 2017.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs