FDA approved Ruxience (rituximab-pvvr) for Non-Hodgkin's Lymphoma, CLL, RA, GPA/MPA, and Pemphigus VulgarisFDA approved new rituximab biosimilar for several blood and autoimmune conditions

FDA From the archive Source published July 23, 2019 Summary added October 2, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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The FDA has approved Ruxience (rituximab-pvvr), a CD20-directed cytolytic antibody, for multiple hematologic and autoimmune indications. The approval covers adult patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and moderate to severe pemphigus vulgaris (PV).

Ruxience is administered only as an intravenous infusion and should be given by a healthcare professional with appropriate medical support to manage severe infusion-related reactions, which can be fatal. Premedication is required before each infusion. The dosing varies by indication: for NHL, 375 mg/m2; for CLL, 375 mg/m2 in cycle 1 and 500 mg/m2 in cycles 2-6; for RA, two 1,000 mg infusions separated by two weeks; for GPA/MPA, induction 375 mg/m2 weekly for four weeks; and for PV, two 1,000 mg infusions separated by two weeks.

This approval provides clinicians with a rituximab biosimilar option across these indications. No clinical trial efficacy data are available in the label.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Ruxience is a CD20-directed cytolytic antibody. CD20 is a protein found on the surface of B cells. The exact mechanism of action in rheumatoid arthritis and pemphigus vulgaris is not fully understood but may involve binding to CD20 on B cells and inducing cell death.

Indication & Patient Population

Ruxience is indicated for the treatment of adult patients with: - Non-Hodgkin's Lymphoma (NHL): 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, as single-agent maintenance therapy; non-progressing (including stable disease), low-grade, CD20-positive B-cell NHL as a single agent after first-line CVP chemotherapy; previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens. - Chronic Lymphocytic Leukemia (CLL): in combination with fludarabine and cyclophosphamide (FC) for previously untreated and previously treated CD20-positive CLL. - Rheumatoid Arthritis (RA): in combination with methotrexate in adult patients with moderately-to-severely-active RA who have had an inadequate response to one or more TNF antagonist therapies. - Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA): in combination with glucocorticoids. - Pemphigus Vulgaris (PV): moderate to severe PV.

Dosing & Administration

Administer only as an intravenous infusion. Do not administer as an intravenous push or bolus. Ruxience should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur. Premedicate before each infusion. - NHL: 375 mg/m2. - CLL: 375 mg/m2 in the first cycle and 500 mg/m2 in Cycles 2-6, in combination with FC, administered every 28 days. - As a component of Zevalin (ibritumomab tiuxetan) Therapeutic Regimen: 250 mg/m2. - RA: two-1,000 mg intravenous infusions separated by 2 weeks (one course) every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks. Methylprednisolone 100 mg intravenous or equivalent glucocorticoid is recommended 30 minutes prior to each infusion. - GPA and MPA: induction dose 375 mg/m2 once weekly for 4 weeks. Follow-up dose for patients who have achieved disease control: two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation. - PV: two-1,000 mg intravenous infusions separated by 2 weeks in combination with a tapering course of glucocorticoids, then a 500 mg intravenous infusion at Month 12 and every 6 months thereafter or based on clinical evaluation. Dose upon relapse is a 1,000 mg intravenous infusion with considerations to resume or increase the glucocorticoid dose based on clinical evaluation. Subsequent infusions may be no sooner than 16 weeks after the previous infusion. Methylprednisolone 100 mg intravenous or equivalent glucocorticoid is recommended 30 minutes prior to each infusion.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment. Severe infusion-related reactions can be

Ruxience is a new drug approved by the FDA. It is a biosimilar to rituximab, which means it is highly similar to an existing approved medicine. It is used to treat several conditions in adults: non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, two types of vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis), and moderate to severe pemphigus vulgaris.

The drug is given only as an intravenous infusion by a healthcare professional. Because serious infusion reactions can occur, patients receive premedication before each dose. Dosing depends on the condition being treated.

This approval gives doctors another rituximab option for these diseases. However, the label does not include clinical trial efficacy data, so it is not known from the label alone how well it works compared to other treatments.

If you have one of these conditions, talk with your doctor about whether Ruxience is right for you. Do not make changes to your treatment without medical advice.

What this means for you:

New biosimilar approved for several blood and autoimmune conditions. Ask your doctor if it is right for you.

Study Details

Study typeFda approval

PublishedJul 2019

View Original Abstract ↓

1 INDICATIONS AND USAGE RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: • Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). o Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. o 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. o 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. o Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. • Adult patients with Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). o Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). • Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ). • Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). • Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ). 1.1 Non-Hodgkin's Lymphoma (NHL) 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. • 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, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2 Chronic Lymphocytic Leukemia (CLL) RUXIENCE, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) RUXIENCE, in combination with methotrexate, is indicated for the treatment of adult patients with moderately-to-severely-active rheumatoid arthritis who have had an inadequate response to one or more Tumor Necrosis Factor (TNF) antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) RUXIENCE, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). 1.5 Pemphigus Vulgaris (PV) RUXIENCE is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.

FDA approved Ruxience (rituximab-pvvr) for Non-Hodgkin's Lymphoma, CLL, RA, GPA/MPA, and Pemphigus VulgarisFDA approved new rituximab biosimilar for several blood and autoimmune conditions

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FDA approved Ruxience (rituximab-pvvr) for Non-Hodgkin's Lymphoma, CLL, RA, GPA/MPA, and Pemphigus VulgarisFDA approved new rituximab biosimilar for several blood and autoimmune conditions

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