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Rituximab - CVP
Rituximab - CVP is a Monoclonal antibody + chemotherapy combination Small molecule drug developed by The Lymphoma Academic Research Organisation. It is currently in Phase 3 development for B-cell non-Hodgkin lymphoma (in combination with CVP chemotherapy), Diffuse large B-cell lymphoma.
Rituximab is a monoclonal antibody that binds to CD20 on B cells and triggers their destruction, combined with CVP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone) to treat lymphoma.
Rituximab is used in combination with Cyclophosphamide and Prednisone (CVP) to treat various types of B-cell lymphomas, including Large B-cell Lymphoma, Follicular Lymphoma, and Non-Hodgkin's Lymphoma. Rituximab works by binding to the B-lymphocyte antigen CD20, a protein found on the surface of B cells.
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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.
| 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 | Rituximab - CVP |
|---|---|
| Sponsor | The Lymphoma Academic Research Organisation |
| Drug class | Monoclonal antibody + chemotherapy combination |
| Target | CD20 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Rituximab targets the CD20 antigen expressed on B-cell lymphomas, leading to antibody-dependent cellular cytotoxicity (ADCC) and direct apoptosis. The CVP chemotherapy component provides additional cytotoxic activity against rapidly dividing lymphoma cells. This combination approach leverages both immunotherapy and conventional chemotherapy mechanisms.
Approved indications
- B-cell non-Hodgkin lymphoma (in combination with CVP chemotherapy)
- Diffuse large B-cell lymphoma
Common side effects
- Infusion reactions
- Neutropenia
- Anemia
- Thrombocytopenia
- Infection
- Nausea/vomiting
- Alopecia
Key clinical trials
- A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients (PHASE3)
- Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy (PHASE2)
- A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma (PHASE3)
- Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma (PHASE2)
- A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma (PHASE3)
- A Phase 3 Open Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma (PHASE3)
- Shortened vs Standard Chemotherapy Combined With Immunotherapy for the Initial Treatment of Patients With High Tumor Burden Follicular Lymphoma (PHASE3)
- Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL: A Randomized, Open Phase II Trial (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 |
|---|---|
| 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:
- Rituximab - CVP CI brief — competitive landscape report
- Rituximab - CVP updates RSS · CI watch RSS
- The Lymphoma Academic Research Organisation portfolio CI
Frequently asked questions about Rituximab - CVP
What is Rituximab - CVP?
How does Rituximab - CVP work?
What is Rituximab - CVP used for?
Who makes Rituximab - CVP?
What drug class is Rituximab - CVP in?
What development phase is Rituximab - CVP in?
What are the side effects of Rituximab - CVP?
What does Rituximab - CVP target?
Related
- Drug class: All Monoclonal antibody + chemotherapy combination drugs
- Target: All drugs targeting CD20
- Manufacturer: The Lymphoma Academic Research Organisation — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for B-cell non-Hodgkin lymphoma (in combination with CVP chemotherapy)
- Indication: Drugs for Diffuse large B-cell lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing