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MabThera/Rituxan
MabThera/Rituxan is a Monoclonal antibody (anti-CD20) Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Non-Hodgkin's lymphoma (B-cell), Chronic lymphocytic leukemia (CLL), Rheumatoid arthritis.
Rituximab is a monoclonal antibody that binds to CD20 on B cells, marking them for destruction by the immune system.
Rituximab is a monoclonal antibody that binds to CD20 on B cells, marking them for destruction by the immune system. Used for Non-Hodgkin's lymphoma (B-cell), Chronic lymphocytic leukemia (CLL), Rheumatoid arthritis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | MabThera/Rituxan |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | Monoclonal antibody (anti-CD20) |
| Target | CD20 |
| Modality | Small molecule |
| Therapeutic area | Oncology, Immunology |
| Phase | Phase 3 |
Mechanism of action
Rituximab targets CD20, a surface antigen expressed on B lymphocytes. By binding to CD20, the antibody facilitates B cell depletion through antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and direct induction of apoptosis. This B cell depletion reduces autoimmune activity in autoimmune diseases and eliminates malignant B cells in lymphomas.
Approved indications
- Non-Hodgkin's lymphoma (B-cell)
- Chronic lymphocytic leukemia (CLL)
- Rheumatoid arthritis
- Granulomatosis with polyangiitis (GPA)
- Microscopic polyangiitis (MPA)
Common side effects
- Infusion reactions
- Infections
- Cytopenias (anemia, thrombocytopenia, neutropenia)
- Fatigue
- Fever
- Nausea
Key clinical trials
- 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)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial (PHASE2)
- Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (PHASE2)
- Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (PHASE3)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- MabThera/Rituxan CI brief — competitive landscape report
- MabThera/Rituxan updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about MabThera/Rituxan
What is MabThera/Rituxan?
How does MabThera/Rituxan work?
What is MabThera/Rituxan used for?
Who makes MabThera/Rituxan?
What drug class is MabThera/Rituxan in?
What development phase is MabThera/Rituxan in?
What are the side effects of MabThera/Rituxan?
What does MabThera/Rituxan target?
Related
- Drug class: All Monoclonal antibody (anti-CD20) drugs
- Target: All drugs targeting CD20
- Manufacturer: Hoffmann-La Roche — full pipeline
- Therapeutic area: All drugs in Oncology, Immunology
- Indication: Drugs for Non-Hodgkin's lymphoma (B-cell)
- Indication: Drugs for Chronic lymphocytic leukemia (CLL)
- Indication: Drugs for Rheumatoid arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing