FDA approval of rituximab-arrx for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia

On December 17, 2020, it was announced that the U.S. Food and Drug Administration (FDA) approved the use of rituximab-arrx, a rituximab biosimilar, for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (also known as Wegener's granulomatosis), and microscopic polyangiitis. This was based on comparative analytical, nonclinical, and clinical data, including results from the phase III JASMINE study (NCT02747043), which compared rituximab-arrx with rituximab in patients with Grade 1, 2, or 3a follicular lymphoma and low tumor burden.¹

Rituximab-arrx¹

• A CD20-directed cytolytic antibody.
• A biosimilar to rituximab; it has an identical dosage, form, and route of administration as intravenous rituximab.

JASMINE study (NCT02747043)^1,2

• A phase III, randomized, double-blind, study comparing the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of rituximab-arrx compared with rituximab in patients with CD20-positive Grade 1, 2, or 3a follicular lymphoma and low tumor burden.
• A total of 256 patients were randomized 1:1 to receive 375 mg/m² intravenous infusion of either rituximab-arrx or rituximab, once weekly for 4 weeks, and at Weeks 12 and 20.
• Primary endpoint: overall response rate by Week 28.
• Results demonstrated no clinically meaningful differences in safety or effectiveness of rituximab-arrx compared with rituximab. Pharmacokinetics, pharmacodynamics, and immunogenicity were also similar in both cohorts.