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FDA Grants Ibrutinib Accelerated Approval for Marginal Zone Lymphoma

December 30, 2021

The U.S. Food and Drug Administration (FDA) granted accelerated approval to ibrutinib for marginal zone lymphoma (MZL) following at least one prior anti-CD20-based therapy.

The decision was based on the results of the pivotal, open-label PCYC-1121 study presented at the 2016 ASH Annual Meeting that found that ibrutinib resulted in an objective response rate of 46 percent, including a complete response rate of 3.2 percent.

A total of 63 patients (median age = 66 years; range = 30-92 years) with relapsed/refractory MZL (including splenic [n=14], nodal [n=17], and extranodal [n=32]) received ibrutinib 560 mg orally once daily. Previous therapies included:

  • splenectomy (6%)
  • radiotherapy (14%)
  • rituximab monotherapy (27%)
  • CD20 antibody-containing chemoimmunotherapy (64%)

After a median follow-up of 19.4 months, the median duration of response and median overall survival were not reached. The median time to initial response was 4.5 months (range = 2.3-16.4 months), and the median progression-free survival was 14.2 months (range = 8.3 months to not reached).

The most common adverse events (AEs) included thrombocytopenia (49%), fatigue (44%), anemia (43%), diarrhea (43%), bruising (41%), musculoskeletal pain (40%), hemorrhage (30%), rash (29%), nausea (25%), peripheral edema (24%), arthralgia (24%), neutropenia (22%), cough (22%), dyspnea (21%), and upper respiratory tract infection (21%). The most common grade 3/4 AEs were increased hemoglobin (13%), decreased neutrophils (13%), and pneumonia (10%). Serious AEs occurred in 28 patients (44%), with grade 3/4 pneumonia being the most common (n=5; 8%).

Three treatment-related AEs resulted in death, and 38 patients (60%) discontinued treatment because of progressive disease (30%), AEs (19%), patient decision (5%), or physician decision (6%). The most common AE leading to treatment discontinuation was diarrhea (n=2; 3%).

The FDA has previously approved ibrutinib for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, and Waldenström macroglobulinemia.

Sources: Abbvie news release, January 19, 2017; 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. Abstract #1213. Presented at the 2016 ASH Annual Meeting, December 5, 2016; San Diego, CA.


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