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