The FDA approved the third biosimilar of the CD20-directed cytolytic antibody rituximab, rituximab-arrx (Riabni), for use in adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA/Wegener’s granulomatosis), and microscopic polyangiitis (MPA).
With this approval, the biosimilar drug should be available to U.S. patients in January 2021 at about three quarters the list price of the original drug, Amgen announced in a company press release.
This approval was based on results from a randomized, double-blind, comparative clinical study that evaluated the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of rituximab-arrx compared to the reference drug among patients with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden, the manufacturer explained.
“There were 256 patients enrolled and randomized (1:1) to receive 375 mg/m2 intravenous infusion of either There were 256 patients enrolled and randomized (1:1) to receive 375 mg/m2 intravenous infusion of either [rituximab-arrx] or [rituximab], once weekly for 4 weeks followed by dosing at weeks 12 and 20,” the company wrote. “The primary endpoint, an assessment of overall response rate (ORR) by week 28, was within the prespecified margin for [rituximab-arrx] compared to [rituximab], showing clinical equivalence. PK, PD, safety, and immunogenicity of [rituximab-arrx] were similar to [rituximab].”
Rituximab and its biosimilars carry a Boxed Warning for fatal infusion-related reactions, severe mucotaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy, and the drug also carries warnings for tumor lysis syndrome, increased infections, cardiac adverse reactions, renal toxicity, and bowel obstruction and perforation. The most common grade 3 or 4 adverse events with rituximab products were infusion-related reactions, neutropenia, leukopenia, anemia, thrombocytopenia, and infections.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 120
Topic ID: 78,120,730,120,466,467,935,192,725,925
