The Food and Drug Administration (FDA) has approved Ruxience (rituximab-pvvr; Pfizer), a biosimilar to Rituxan (Genentech and Biogen), for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangitis and microscopic polyangiitis.
The approval was based on a comprehensive data package which included results from the REFLECTIONS B3281006 study in which the safety, efficacy, pharmacokinetics and immunogenicity of the biosimilar was compared with the reference product. The study met its primary end point of equivalence in overall response rate in patients with CD20-positive, low tumor burden, follicular lymphoma.
Like the reference product, Ruxience, a CD20-directed cytolytic antibody, carries a Boxed Warning regarding the risk of fatal infusion reactions, severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy (PML).
“With this FDA approval, clinicians have an additional treatment option that will help improve access to care for patients in need of anti-CD20 mAb therapy,” said Dr Jeff Sharman, medical director, US Oncology Hematology Research.
Ruxience will be supplied in single-dose vials as a 100mg/10mL and 500mg/50mL solution for intravenous infusion.
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