The Food and Drug Administration (FDA) has approved Imbruvica (ibrutinib; Janssen and Pharmacyclics) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received ≥1 prior anti-CD20-based therapy. 

The expanded approval was supported by data from the PCYC-1121 trial, a Phase 2, multi-center, open-label, single-arm trial (n=63) evaluating the safety and efficacy of Imbruvica in patients with MZL who received ≥1 prior therapy. In these patients, overall response rate (ORR) was 46% (95% CI: 33.4–59.1) with 3.2% of patients achieving complete responses (CR) and 42.9% achieving partial responses (PR). 

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Efficacy was seen across all three MZL subtypes: mucosa-associated lymphoid tissue (MALT; ORR 46.9%), nodal MZL (ORR 41.2%), and splenic MZL (ORR 50.0%). The median time to initial response was 4.5 months (2.3–16.4). The median duration of response (DOR) was not reached, with median follow-up time of 19.4 months. The accelerated approval was granted based on ORR data, and continued approval for this indication may be contingent upon clinical benefit findings in a confirmatory trial. 

Imbruvica, a Bruton’s tyrosine kinase (BTK) inhibitor, is currently approved to treat Mantle cell lymphoma (MCL) in patients who have received at least one prior therapy, chronic lymphocytic leukemia (CLL), CLL in patients with 17p deletion, and Waldenstrom’s macroglobulinemia (WM). It is available as 140mg strength capsules in 90- and 120-count bottles.

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