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Rituximab - CVP

The Lymphoma Academic Research Organisation · Phase 3 active Small molecule Under review Quality 0/100

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.

Likelihood of approval
61.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameRituximab - CVP
SponsorThe Lymphoma Academic Research Organisation
Drug classMonoclonal antibody + chemotherapy combination
TargetCD20
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 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

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Rituximab - CVP

What is Rituximab - CVP?

Rituximab - CVP is a Monoclonal antibody + chemotherapy combination drug developed by The Lymphoma Academic Research Organisation, indicated for B-cell non-Hodgkin lymphoma (in combination with CVP chemotherapy), Diffuse large B-cell lymphoma.

How does Rituximab - CVP work?

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.

What is Rituximab - CVP used for?

Rituximab - CVP is indicated for B-cell non-Hodgkin lymphoma (in combination with CVP chemotherapy), Diffuse large B-cell lymphoma.

Who makes Rituximab - CVP?

Rituximab - CVP is developed by The Lymphoma Academic Research Organisation (see full The Lymphoma Academic Research Organisation pipeline at /company/the-lymphoma-academic-research-organisation).

What drug class is Rituximab - CVP in?

Rituximab - CVP belongs to the Monoclonal antibody + chemotherapy combination class. See all Monoclonal antibody + chemotherapy combination drugs at /class/monoclonal-antibody-chemotherapy-combination.

What development phase is Rituximab - CVP in?

Rituximab - CVP is in Phase 3.

What are the side effects of Rituximab - CVP?

Common side effects of Rituximab - CVP include Infusion reactions, Neutropenia, Anemia, Thrombocytopenia, Infection, Nausea/vomiting.

What does Rituximab - CVP target?

Rituximab - CVP targets CD20 and is a Monoclonal antibody + chemotherapy combination.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing