FDA Approves Ruxience, a Rituxan Biosimilar

The FDA approved Ruxience (rituximab-pvvr, Pfizer), a biosimilar of Rituxan (rituximab, Genentech) for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL); chronic lymphocytic leukemia (CLL); and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in combination with glucocorticoids. 

Ruxience is a CD20-directy cytolytic antibody.

“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 statement.

Approval is based upon the Reflections B3281006 comparative study, which demonstrated no clinically meaningful difference in safety or efficacy compared to Rituxan in patients with CD20-positive low-tumor-burden follicular lymphoma. 

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“Biosimilars like Ruxience have the potential to deliver real value in healthcare, improving access to and affordability of an important cancer treatment which could help more patients receive optimal care,” said Andy Schmeltz, Global President, Pfizer Oncology in a statement. 

Boxed warnings include: 

• Fatal infusion-related reactions that may occur within 24 hours of infusion, with approximately 80% occurring with the first infusion

• Severe mucocutaneous reactions, some with fatal outcomes 

• Hepatitis B virus reactivation, resulting in some cases of fulminant hepatitis, hepatic failure, and death

• Progressive multifocal leukoencephalopathy resulting in death 

Other warnings in the prescribing information for Ruxience include tumor lysis syndrome, cardiac adverse reactions, renal toxicity, bowel obstruction and perforation, embryo-fetal toxicity. Ruxience should be withheld until the completion of anti-infective therapies in the case of infections and is not recommended with or immediately after live virus vaccinations. 

Renal toxicity may develop when Ruxience is used in combination with cisplatin. 

Adverse reactions for all conditions treatable with Ruxience include fever, lymphopenia, chills, infection, asthenia, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema. See prescribing information for specific condition-related reactions. 

Full Prescribing Information