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Recombinant Flt3 Ligand
Recombinant Flt3 Ligand is a Cytokine; Hematopoietic growth factor Biologic drug developed by University of Southern California. It is currently in Phase 3 development for Cancer immunotherapy (in combination with other agents), Hematopoietic stem cell mobilization. Also known as: CDX-301, FLT 3 Ligand, FLT3 Ligand, Flt3-Ligand.
Recombinant Flt3 Ligand stimulates the proliferation and differentiation of hematopoietic stem cells and progenitor cells by binding to the Flt3 receptor.
Recombinant Flt3 Ligand is a treatment being studied in clinical trials for various conditions, including Leukemia, Breast Cancer, Lymphoma, Multiple Myeloma, and Plasma Cell Neoplasm. It is an enzyme that hydrolyzes hyaluronic acid, and its mechanism of action is related to this enzymatic activity.
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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 | Recombinant Flt3 Ligand |
|---|---|
| Also known as | CDX-301, FLT 3 Ligand, FLT3 Ligand, Flt3-Ligand, Flt3L |
| Sponsor | University of Southern California |
| Drug class | Cytokine; Hematopoietic growth factor |
| Target | Flt3 receptor (FLT3) |
| Modality | Biologic |
| Therapeutic area | Oncology; Immunology |
| Phase | Phase 3 |
Mechanism of action
Flt3 Ligand is a cytokine that acts as a growth factor for early hematopoietic cells. By engaging the Flt3 receptor on bone marrow progenitors, it promotes expansion of multiple cell lineages including dendritic cells, which can enhance immune responses. This mobilization of immune cells has been explored therapeutically in cancer immunotherapy and hematopoietic recovery contexts.
Approved indications
- Cancer immunotherapy (in combination with other agents)
- Hematopoietic stem cell mobilization
Common side effects
- Bone pain
- Splenomegaly
- Fever
- Fatigue
Key clinical trials
- In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors (PHASE1)
- CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer (PHASE1)
- FLT3 Ligand Immunotherapy and Stereotactic Radiotherapy for Advanced Non-small Cell Lung Cancer (PHASE2)
- Biological, Prospective Study Evaluating the Dosage of Plasma Cytokines Including the FLT3 Ligand and IL6 of Patients Treated With Non-intensive Chemotherapy
- A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies (PHASE1)
- flt3L With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma or Renal Cell Cancer (PHASE2)
- FLT3 Ligand, CD40 Agonist Antibody, and Stereotactic Radiotherapy (PHASE1, PHASE2)
- Vaccination With Flt3L, Radiation, and Poly-ICLC (PHASE1, 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:
- Recombinant Flt3 Ligand CI brief — competitive landscape report
- Recombinant Flt3 Ligand updates RSS · CI watch RSS
- University of Southern California portfolio CI
Frequently asked questions about Recombinant Flt3 Ligand
What is Recombinant Flt3 Ligand?
How does Recombinant Flt3 Ligand work?
What is Recombinant Flt3 Ligand used for?
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Is Recombinant Flt3 Ligand also known as anything else?
What drug class is Recombinant Flt3 Ligand in?
What development phase is Recombinant Flt3 Ligand in?
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What does Recombinant Flt3 Ligand target?
Related
- Drug class: All Cytokine; Hematopoietic growth factor drugs
- Target: All drugs targeting Flt3 receptor (FLT3)
- Manufacturer: University of Southern California — full pipeline
- Therapeutic area: All drugs in Oncology; Immunology
- Indication: Drugs for Cancer immunotherapy (in combination with other agents)
- Indication: Drugs for Hematopoietic stem cell mobilization
- Also known as: CDX-301, FLT 3 Ligand, FLT3 Ligand, Flt3-Ligand, Flt3L
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing