All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.

  TRANSLATE

The lym Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the lym Hub cannot guarantee the accuracy of translated content. The lym and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

The Lymphoma & CLL Hub is an independent medical education platform, sponsored by AbbVie, BeOne Medicines, Johnson & Johnson, Roche, and Sobi, and supported through educational grants from Bristol Myers Squibb, Incyte, Lilly, and Pfizer.   View funders.

Now you can support HCPs in making informed decisions for their patients

Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.

Find out more

FDA approves rituximab-pvvr, 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, 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

References

Your opinion matters

Which of the following would most increase your confidence in referring patients with R/R large B-cell lymphoma for CAR T-cell therapy?