The FDA has approved PF-05280586 (rituximab-pvvr; Ruxience), a biosimilar for rituximab (Rituxan), for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy, or for patients with CD20-positive chronic lymphocytic leukemia (CLL) in combination with chemotherapy.
Additionally, this is the first biosimilar approved to treat patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangitis (MPA). This is the second rituximab biosimilar approved by the FDA.
The approval is based on a review of a comprehensive data package, which demonstrated biosimilarity of PF-05280586 to reference rituximab. The package includes findings from the REFLECTIONS B3281006 clinical comparative study, which showed there were no clinically meaningful differences in efficacy or safety versus reference rituximab in patients with CD20-positive, low tumor burden follicular lymphoma.
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