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Mabthera (rituxan)
Mabthera (Rituxan) is a CD20-directed cytolytic antibody developed by Genentech, targeting B-lymphocytes. It is a small molecule modality, FDA-approved in 1997 for various B-cell malignancies and autoimmune diseases. Mabthera is currently owned by Genentech and is not off-patent. Key safety considerations include infusion reactions, neutropenia, and increased risk of infections. As a patented product, it is not yet available as a generic.
At a glance
| Generic name | rituxan |
|---|---|
| Sponsor | Roche |
| Drug class | CD20-directed Cytolytic Antibody |
| Target | B-lymphocyte antigen CD20 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1997 |
| Annual revenue | 3800 |
Approved indications
- Burkitt cell leukemia
- Burkitt's lymphoma
- CD20 positive diffuse large B cell non Hodgkin's lymphoma
- Chronic lymphoid leukemia, disease
- Follicular lymphoma
- Granulomatosis with polyangiitis
- Microscopic polyangiitis
- Microscopic polyarteritis nodosa
- Neuromyelitis optica
- Non-Hodgkin's lymphoma
- Pemphigus foliaceus
- Pemphigus vulgaris
- Rheumatoid arthritis
- Systemic sclerosis
- Thrombotic thrombocytopenic purpura
Common side effects
- Infections
- Neutropenia
- Nausea
- Constipation
- Cough
- Fatigue
- Alopecia
- Anemia
- Thrombocytopenia
- Pyrexia
- Vomiting
- Injection site erythema
Key clinical trials
- A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy (PHASE3)
- A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis (PHASE3)
- A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate (PHASE3)
- A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis (PHASE3)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma (PHASE2)
- A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) (PHASE2,PHASE3)
- Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia (PHASE1,PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |