FDA approves Ruxience (rituximab-pvvr), biosimilar to Rituxan (rituximab)

FDA approves Ruxience (rituximab-pvvr), biosimilar to Rituxan (rituximab)

The U.S Food and Drug Administration (FDA) today approved Ruxience (rituximab-pvvr), a biosimilar to U.S.-licensed Rituxan (rituximab) for the treatment of adult patients with CD20-positive B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy, and CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination with chemotherapy. Ruxience is also the first biosimilar approved to treat Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangitis (MPA). Ruxience is the 2nd biosimiliar to be approved in the U.S. for Rituxan and the 22nd FDA approved biosimilar product.

Ruxience is indicated for the treatment of adult patients with:

• Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent;
• Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and
• Non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy;
• Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens;
• Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC);
• Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.

The most common side effects of Ruxience are infusion-related reactions, fever, low white blood cells (lymphopenia, neutropenia), chills, infection, weakness, nausea, diarrhea, headache, muscle spasms, low red blood cells (anemia), and swelling (peripheral edema). Health care providers are advised to monitor patients for tumor lysis syndrome (a complication from tumor cells dying and releasing their contents into the bloodstream), infections, cardiac adverse reactions, damage to kidneys (renal toxicity), and bowel obstruction and perforation. Patients should not receive live vaccinations before or during treatment. Women who are pregnant or breastfeeding should not take Ruxience because it may cause harm to a developing fetus or newborn baby.

Like U.S.-licensed Rituxan, the labeling for Ruxience contains a Boxed Warning to alert health care professionals and patients about increased risks of the following: fatal infusion-related reactions, severe skin and mouth reactions, some with fatal outcomes; Hepatitis B virus reactivation, which may cause serious liver problems including liver failure and death; and progressive multifocal leukoencephalopathy (PML), a rare, serious brain infection that can result in severe disability or death. This product must be dispensed with a patient Medication Guide that provides important information about the product’s uses and risks.

For more information, please visit: Ruxience.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. For more information about biosimilar products, visit www.fda.gov/biosimilars.