You are here

Biosimilar Ruxience Approved for Some Blood Cancers and Autoimmune Conditions

May Be Used in Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Polyangiitis

The FDA has approved rituximab-pvvr (Ruxience, Pfizer), a rituximab biosimilar (Rituxan), for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

Rituximab-pvvr is a mAb biosimilar to Rituxan that targets the protein CD20, which is present on the surface of B cells. When it attaches to CD20, rituximab helps destroy the B cells.

The approval was based on a review of data demonstrating rituximab-pvvr’s biosimilarity to the reference product, including results from the REFLECTIONS B3281006 clinical comparative study. The study evaluated the efficacy, safety and immunogenicity, pharmacokinetics, and pharmacodynamics of rituximab-pvvr.

The most common side effects reported in patients treated with rituximab-pvvr are infusion-related reactions, fever, lymphopenia, neutropenia, chills, infection, weakness, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema.

Source: Centers for Biosimilars and Healio, July 23, 2019

Recent Headlines

Citrus, Berries, Broccoli Reduce Risk of Cancer and CVD
Changes in Antibiotic Recommendations for Children
Influences Gene Involved in Circadian Rhythms
‘The Perfect Drug for Trauma-Focused Psychotherapy’
Triggers the Body’s Own Natural Blood Flow Regulation
Inrebic Reduces Symptoms by 50% in Some Patients
Novel Catheter-based Technology for Treating Acute Ischemic Stroke
Decision supported by data from more than 4,000 patients