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EGFR-TKI
EGFR-TKI is a EGFR tyrosine kinase inhibitor Small molecule drug developed by Sichuan Cancer Hospital and Research Institute. It is currently in Phase 3 development for Non-small cell lung cancer with EGFR mutations, Other EGFR-driven solid tumors. Also known as: Imatinib、Gefitinib or Erlotinib, Gefitinib/Tarceva/Icotinib, gefitinib, Gefitinib/Erlotinib/Icotinib.
EGFR-TKI inhibits epidermal growth factor receptor tyrosine kinase activity to block cancer cell proliferation and survival signaling.
EGFR-TKI is used to treat Non-Small Cell Lung Cancer (NSCLC) and has been studied in combination with other treatments such as chemotherapy and other medications like Gefitinib. The mechanism of EGFR-TKI involves targeting the epidermal growth factor receptor (EGFR) to inhibit cancer cell growth.
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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 | EGFR-TKI |
|---|---|
| Also known as | Imatinib、Gefitinib or Erlotinib, Gefitinib/Tarceva/Icotinib, gefitinib, Gefitinib/Erlotinib/Icotinib, Erlotinib:150 mg oral, once a day,Tarceva |
| Sponsor | Sichuan Cancer Hospital and Research Institute |
| Drug class | EGFR tyrosine kinase inhibitor |
| Target | EGFR (epidermal growth factor receptor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
EGFR-TKIs are small-molecule inhibitors that bind to the ATP-binding pocket of EGFR's intracellular tyrosine kinase domain, preventing autophosphorylation and downstream signaling through pathways like MAPK and PI3K/AKT. This mechanism is particularly effective in cancers with EGFR mutations or overexpression, leading to cell cycle arrest and apoptosis.
Approved indications
- Non-small cell lung cancer with EGFR mutations
- Other EGFR-driven solid tumors
Common side effects
- Rash/acneiform dermatitis
- Diarrhea
- Nausea
- Fatigue
- Interstitial lung disease
Key clinical trials
- TILs Plus Third-Generation EGFR-TKI Therapy for TKI-Resistant NSCLC (EARLY_PHASE1)
- CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC
- Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC (PHASE2)
- Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (PHASE3)
- Phase III Study of AK112 for NSCLC Patients (PHASE3)
- Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01) (PHASE2, PHASE3)
- A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC (PHASE3)
- A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (PHASE1)
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:
- EGFR-TKI CI brief — competitive landscape report
- EGFR-TKI updates RSS · CI watch RSS
- Sichuan Cancer Hospital and Research Institute portfolio CI
Frequently asked questions about EGFR-TKI
What is EGFR-TKI?
How does EGFR-TKI work?
What is EGFR-TKI used for?
Who makes EGFR-TKI?
Is EGFR-TKI also known as anything else?
What drug class is EGFR-TKI in?
What development phase is EGFR-TKI in?
What are the side effects of EGFR-TKI?
What does EGFR-TKI target?
Related
- Drug class: All EGFR tyrosine kinase inhibitor drugs
- Target: All drugs targeting EGFR (epidermal growth factor receptor)
- Manufacturer: Sichuan Cancer Hospital and Research Institute — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer with EGFR mutations
- Indication: Drugs for Other EGFR-driven solid tumors
- Also known as: Imatinib、Gefitinib or Erlotinib, Gefitinib/Tarceva/Icotinib, gefitinib, Gefitinib/Erlotinib/Icotinib, Erlotinib:150 mg oral, once a day,Tarceva
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing