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FDA approves rituximab-pvvr (Ruxience®), a rituximab biosimilar, for the treatment of patients with CD20-positive NHL and CLL

Jul 25, 2019

On 23 July 2019, the US Food and Drug Administration (FDA) approved rituximab-pvvr (Ruxience®), a monoclonal antibody biosimilar to rituximab, for multiple indications in adult patients with CD20-positive B-cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL)1:

  • Monotherapy for relapsed or refractory, low-grade or follicular NHL
  • In combination with first-line chemotherapy for previously untreated follicular lymphoma and, as single-agent maintenance therapy in patients responding to a rituximab-chemotherapy combination
  • Single agent for non-progressing, low-grade NHL after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
  • In combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens for previously untreated diffuse large B-cell lymphoma
  • In combination with fludarabine and cyclophosphamide (FC) in previously untreated and previously treated CLL

Rituximab-pvvr is the second biosimilar to rituximab that has been approved by the FDA; the first being rituximab-abbs (Truxima®) which was previously covered by the Lymphoma Hub in November 2018. Both biosimilar antibodies destroy B cells by targeting surface protein CD20.

The approval of rituximab-pvvr was based on a review of a comprehensive data package, includingthe clinical comparative study REFLECTIONS B3281006, which demonstrated the biosimilarity of rituximab-pvvr to the reference product, rituximab. The study included patients with CD20-positive, low tumor burden follicular lymphoma, and no clinically meaningful differences in safety or efficacy were found between rituximab-pvvr and the reference product.2

  1. RUXIENCE™ (rituximab-pvvr) Prescribing Information. New York. NY: Pfizer Inc: 2019. Available at Accessed 23 July 2019
  2. Sharman J, et al. A Randomized, Double-Blind Efficacy and Safety Study of PF-05280586 (a Potential Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low Tumor Burden Follicular Lymphoma (LTB-FL). Blood. 2018; 132:394