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CEP-701
CEP-701 is a FLT3 inhibitor Small molecule drug developed by Cephalon. It is currently in Phase 2 development. Also known as: lestaurtinib.
CEP-701 inhibits FLT3 receptor tyrosine kinase, blocking signaling pathways that promote cancer cell growth and survival.
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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 | CEP-701 |
|---|---|
| Also known as | lestaurtinib |
| Sponsor | Cephalon |
| Drug class | FLT3 inhibitor |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
CEP-701 is a selective inhibitor of FLT3, a receptor tyrosine kinase that is frequently mutated or overexpressed in acute myeloid leukemia. By blocking FLT3 signaling, the drug aims to inhibit proliferation and induce apoptosis in leukemia cells harboring FLT3 mutations.
Approved indications
Common side effects
Key clinical trials
- Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (PHASE3)
- N2001-03: CEP-701 in Treating Young Patients With Recurrent or Refractory High-Risk Neuroblastoma (PHASE1)
- Lestaurtinib, Cytarabine, and Idarubicin in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia (PHASE1, PHASE2)
- Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML) (PHASE2)
- Lestaurtinib With or Without Chemotherapy Agents in Samples From Young Patients With Leukemia
- Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis (PHASE2)
- CEP-701 (Lestaurtinib) in Myelofibrosis (PHASE1, PHASE2)
- Study of CEP-701 in Treatment of Prostate Cancer (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:
- CEP-701 CI brief — competitive landscape report
- CEP-701 updates RSS · CI watch RSS
- Cephalon portfolio CI
Frequently asked questions about CEP-701
What is CEP-701?
How does CEP-701 work?
Who makes CEP-701?
Is CEP-701 also known as anything else?
What drug class is CEP-701 in?
What development phase is CEP-701 in?
Related
- Drug class: All FLT3 inhibitor drugs
- Manufacturer: Cephalon — full pipeline
- Also known as: lestaurtinib