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Bendamustine, Lenalidomide, Rituximab
Bendamustine, Lenalidomide, Rituximab is a Chemotherapy agent, Immunomodulator, Monoclonal antibody Small molecule drug developed by Fondazione Italiana Linfomi - ETS. It is currently in Phase 2 development for Chronic lymphocytic leukemia, Non-Hodgkin's lymphoma.
Bendamustine is a chemotherapy medication that works by interfering with DNA replication, Lenalidomide is an immunomodulatory drug that affects the immune system, Rituximab is a monoclonal antibody that targets CD20 on B cells.
Bendamustine, Lenalidomide, and Rituximab are used to treat various types of lymphoma, including Chronic Lymphocytic Leukemia, Relapsed or Refractory Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma. Rituximab, a B-lymphocyte antigen CD20 binding agent, is an antibody that targets and binds to CD20, a protein found on the surface of B cells.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Bendamustine, Lenalidomide, Rituximab |
|---|---|
| Sponsor | Fondazione Italiana Linfomi - ETS |
| Drug class | Chemotherapy agent, Immunomodulator, Monoclonal antibody |
| Target | CD20, DNA replication |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Bendamustine is a nitrogen mustard alkylating agent that induces DNA cross-links and strand breaks, leading to cell death. Lenalidomide enhances T-cell and natural killer cell activity, and also has immunomodulatory effects. Rituximab binds to CD20 on B cells, leading to their depletion and reduction of B-cell mediated inflammation.
Approved indications
- Chronic lymphocytic leukemia
- Non-Hodgkin's lymphoma
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Fatigue
- Nausea
Key clinical trials
- CD20 Monoclonal Antibody-Based First-Line Therapy in Treatment-Naive Marginal Zone B-Cell Lymphoma
- A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma (PHASE3)
- Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (PHASE1, PHASE2)
- Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma (PHASE3)
- A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma (PHASE3)
- Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma (PHASE3)
- A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma (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:
- Bendamustine, Lenalidomide, Rituximab CI brief — competitive landscape report
- Bendamustine, Lenalidomide, Rituximab updates RSS · CI watch RSS
- Fondazione Italiana Linfomi - ETS portfolio CI
Frequently asked questions about Bendamustine, Lenalidomide, Rituximab
What is Bendamustine, Lenalidomide, Rituximab?
How does Bendamustine, Lenalidomide, Rituximab work?
What is Bendamustine, Lenalidomide, Rituximab used for?
Who makes Bendamustine, Lenalidomide, Rituximab?
What drug class is Bendamustine, Lenalidomide, Rituximab in?
What development phase is Bendamustine, Lenalidomide, Rituximab in?
What are the side effects of Bendamustine, Lenalidomide, Rituximab?
What does Bendamustine, Lenalidomide, Rituximab target?
Related
- Drug class: All Chemotherapy agent, Immunomodulator, Monoclonal antibody drugs
- Target: All drugs targeting CD20, DNA replication
- Manufacturer: Fondazione Italiana Linfomi - ETS — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chronic lymphocytic leukemia
- Indication: Drugs for Non-Hodgkin's lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing