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Cyclophosphamide, Prednisone, Lenalidomide
Cyclophosphamide, Prednisone, Lenalidomide is a Combination chemotherapy and immunomodulatory therapy Small molecule drug developed by Fondazione EMN Italy Onlus. It is currently in Phase 3 development for Multiple myeloma (likely indication based on typical use of this triplet).
This combination uses cyclophosphamide and prednisone as immunosuppressive/chemotherapy agents alongside lenalidomide, an immunomodulatory drug that enhances T-cell proliferation and has anti-angiogenic properties.
This combination uses cyclophosphamide and prednisone as immunosuppressive/chemotherapy agents alongside lenalidomide, an immunomodulatory drug that enhances T-cell proliferation and has anti-angiogenic properties. Used for Multiple myeloma (likely indication based on typical use of this triplet).
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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 | Cyclophosphamide, Prednisone, Lenalidomide |
|---|---|
| Sponsor | Fondazione EMN Italy Onlus |
| Drug class | Combination chemotherapy and immunomodulatory therapy |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Cyclophosphamide is an alkylating agent that damages DNA in rapidly dividing cells; prednisone is a corticosteroid that suppresses immune responses; lenalidomide is an IMiD that binds cereblon, enhancing immune cell activation while inhibiting angiogenesis and promoting apoptosis in malignant cells. Together, this triplet combination leverages chemotherapy, immunosuppression, and immunomodulation for treating hematologic malignancies.
Approved indications
- Multiple myeloma (likely indication based on typical use of this triplet)
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Infection
- Neuropathy
- Fatigue
- Nausea and vomiting
- Hemorrhagic cystitis
- Thromboembolism
Key clinical trials
- Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL) (PHASE1)
- Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (PHASE2)
- Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma (PHASE2)
- 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)
- Lenalidomide and Combination Chemotherapy (DA-EPOCH-R) in Treating Patients With MYC-Associated B-Cell Lymphomas (PHASE1, PHASE2)
- Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome (PHASE1, PHASE2)
- A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin 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:
- Cyclophosphamide, Prednisone, Lenalidomide CI brief — competitive landscape report
- Cyclophosphamide, Prednisone, Lenalidomide updates RSS · CI watch RSS
- Fondazione EMN Italy Onlus portfolio CI
Frequently asked questions about Cyclophosphamide, Prednisone, Lenalidomide
What is Cyclophosphamide, Prednisone, Lenalidomide?
How does Cyclophosphamide, Prednisone, Lenalidomide work?
What is Cyclophosphamide, Prednisone, Lenalidomide used for?
Who makes Cyclophosphamide, Prednisone, Lenalidomide?
What drug class is Cyclophosphamide, Prednisone, Lenalidomide in?
What development phase is Cyclophosphamide, Prednisone, Lenalidomide in?
What are the side effects of Cyclophosphamide, Prednisone, Lenalidomide?
Related
- Drug class: All Combination chemotherapy and immunomodulatory therapy drugs
- Manufacturer: Fondazione EMN Italy Onlus — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma (likely indication based on typical use of this triplet)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing