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FDA approves Imbruvica for relapsed, refractory marginal zone lymphoma
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The FDA approved ibrutinib for the treatment of patients with relapsed or refractory marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20–based therapy, according to a press release.
Ibrutinib (Imbruvica; Pharmacyclics and Janssen Biotech) is the first FDA–approved treatment specifically indicated for relapsed or refractory marginal zone lymphoma.
“The FDA approval of Imbruvica for relapsed/refractory marginal zone lymphoma is significant, and we are proud of the culmination of this extensive clinical research program, representing the first approved treatment specifically for patients with this rare type of non-Hodgkin lymphoma," Darrin Beaupre, MD, PhD, head of early development and immunotherapy at Pharmacyclics, said in the release. “This milestone marks the fifth patient population for whom Imbruvica is now approved and broadens the number of patients who may be treated with the medication. We continue to research Imbruvica across many disease areas, including but not limited to other B-cell malignancies.”
The approval is based, in part, on data from the phase 2, open-label, single-arm PCYC-1121 study, which was designed to evaluate the safety and efficacy of ibrutinib in patients with marginal zone lymphoma who required systemic therapy and received at least one prior anti-CD20–based therapy. The study included 63 patients with three marginal zone lymphoma subtypes — mucosa-associated lymphoid tissue (n = 32), nodal (n = 17) and splenic (n = 14).
Results of the study — presented at the ASH Annual Meeting and Exposition — showed 46% (95% CI, 33.4-59.1) of patients responded to treatment, including patients from each subtype. This included 3.2% of patients who had a complete response and 42.9% of patients with a partial response.
The median time to response was 4.5 months (range, 2.3-16.4), and the median duration of response was not reached (range, 16.7 months-not reached).
“In the phase 2 trial, Imbruvica demonstrated impressive response rates and duration of response in relapsed/refractory marginal zone lymphoma patients,” study researcher Ariela Noy, MD, hematologic oncologist at Memorial Sloan Kettering Cancer Center, said in the release. “The hematology/oncology community welcomes a new option like Imbruvica, which helps fill a significant treatment gap for previously treated marginal zone lymphoma patients who are in need of non-chemotherapy options.”
The safety profile of ibrutinib in the phase 2 trial appeared consistent with that known for other 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 and cough (22% each), and dyspnea and upper respiratory tract infection (21% each). The most common grade 3 or grade 4 adverse events included decreases in hemoglobin and neutrophils (13% each) and pneumonia (10%).
Ibrutinib is also approved to treat patients with chronic lymphocytic leukemia/small lymphocytic lymphoma including patients with 17p deletion; patients with mantle cell lymphoma who have received at least one prior therapy; and patients with Waldenström macroglobulinemia.