Last reviewed · How we verify
Fludarabine plus Cyclophosphamide
Fludarabine plus Cyclophosphamide is a Chemotherapy combination (purine analog + alkylating agent) Small molecule drug developed by German CLL Study Group. It is currently in Phase 3 development for Chronic lymphocytic leukemia (CLL), B-cell non-Hodgkin lymphoma.
Fludarabine and cyclophosphamide work together as a chemotherapy combination that damages cancer cell DNA and suppresses immune function to treat chronic lymphocytic leukemia.
Fludarabine is a small molecule inhibitor of the enzyme ribonucleoside-diphosphate reductase RR1. It is used in combination with Cyclophosphamide to treat various cancers, including Hepatocellular Carcinoma, Human Papillomavirus-Related Carcinomas, and others.
-
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 | Fludarabine plus Cyclophosphamide |
|---|---|
| Sponsor | German CLL Study Group |
| Drug class | Chemotherapy combination (purine analog + alkylating agent) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fludarabine is a purine analog that inhibits DNA synthesis and repair in lymphoid cells, while cyclophosphamide is an alkylating agent that cross-links DNA strands, causing cell death. Together, they create a synergistic cytotoxic effect against malignant B-lymphocytes in CLL. The combination also provides immunosuppression, which can be beneficial in autoimmune-mediated hematologic conditions.
Approved indications
- Chronic lymphocytic leukemia (CLL)
- B-cell non-Hodgkin lymphoma
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Infection
- Nausea and vomiting
- Fatigue
- Mucositis
- Diarrhea
- Hemorrhage
- Secondary malignancy
Key clinical trials
- Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL (PHASE1, PHASE2)
- A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (PHASE3)
- RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy (PHASE2, PHASE3)
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers (PHASE1, PHASE2)
- Pilot Study of Reduced-Intensity Hematopoietic Stem Cell Transplant of DOCK8 Deficiency (PHASE2)
- Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma (PHASE1)
- A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab (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:
- Fludarabine plus Cyclophosphamide CI brief — competitive landscape report
- Fludarabine plus Cyclophosphamide updates RSS · CI watch RSS
- German CLL Study Group portfolio CI
Frequently asked questions about Fludarabine plus Cyclophosphamide
What is Fludarabine plus Cyclophosphamide?
How does Fludarabine plus Cyclophosphamide work?
What is Fludarabine plus Cyclophosphamide used for?
Who makes Fludarabine plus Cyclophosphamide?
What drug class is Fludarabine plus Cyclophosphamide in?
What development phase is Fludarabine plus Cyclophosphamide in?
What are the side effects of Fludarabine plus Cyclophosphamide?
Related
- Drug class: All Chemotherapy combination (purine analog + alkylating agent) drugs
- Manufacturer: German CLL Study Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chronic lymphocytic leukemia (CLL)
- Indication: Drugs for B-cell non-Hodgkin lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing