FDA Approves Ruxience Biosimlar to Rituxan

The FDA approved rituximab-pvvr, a rituximab biosimilar, for use alone or in combination with chemotherapy for the treatment of adults with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL), as well as granulomatosis with polyangiitis and microscopic polyangiitis. This is the second biosimilar to rituximab that has been approved by the FDA.

This approval was based on a review of comprehensive data demonstrating the biosimilarity of rituximab-pvvr to the reference drug, rituximab.

“Rituximab became one of the first monoclonal antibody (mAb) cancer treatments when it was initially approved by the FDA, representing a significant treatment advance and the only option available to oncologists and their patients for a period of time,” said Jeff Sharman, MD, Medical Director, US Oncology Hematology Research, in a press release.

“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,” he added.

The most common adverse effects of rituximab-pvvr are infusion-related reactions, fever, low white blood cells count, chills, infection, weakness, nausea, diarrhea, headache, muscle spasms, low red blood cell count, and swelling.

Source: FDA approves Pfizer’s biosimilar, RUXIENCE (rituximab-pvvr), for certain cancers and autoimmune conditions [news release]. New York, NY: Business Wire; July 23, 2019. https://www.businesswire.com/news/home/20190723005823/en/FDA-Approves-Pfizer%E2%80%99s-Biosimilar-RUXIENCE%E2%84%A2-rituximab-pvvr-Cancers. Accessed July 23, 2019.

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