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Lenalidomide and Rituximab
Lenalidomide and Rituximab is a Small molecule drug developed by Chronic Lymphocytic Leukemia Research Consortium. It is currently in Phase 2 development. Also known as: Revlimid, CC-5013, Rituxan.
Lenalidomide is a binding agent used to treat various types of lymphoma, including Relapsed Follicular Lymphoma, Refractory Follicular Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Diffuse Large B-Cell Lymphoma. Rituximab is an antibody that binds to the B-lymphocyte antigen CD20, used to treat the same conditions as Lenalidomide.
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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).
| 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 | Lenalidomide and Rituximab |
|---|---|
| Also known as | Revlimid, CC-5013, Rituxan |
| Sponsor | Chronic Lymphocytic Leukemia Research Consortium |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery (PHASE1)
- Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma (PHASE2)
- Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma (PHASE1)
- Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma (PHASE1)
- 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)
- Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma (PHASE1)
- A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma (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:
- Lenalidomide and Rituximab CI brief — competitive landscape report
- Lenalidomide and Rituximab updates RSS · CI watch RSS
- Chronic Lymphocytic Leukemia Research Consortium portfolio CI
Frequently asked questions about Lenalidomide and Rituximab
What is Lenalidomide and Rituximab?
Who makes Lenalidomide and Rituximab?
Is Lenalidomide and Rituximab also known as anything else?
What development phase is Lenalidomide and Rituximab in?
Related
- Manufacturer: Chronic Lymphocytic Leukemia Research Consortium — full pipeline
- Also known as: Revlimid, CC-5013, Rituxan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing