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EGFR-TK Inhibitor
EGFR-TK Inhibitor is a EGFR tyrosine kinase inhibitor Small molecule drug developed by Xinqiao Hospital of Chongqing. It is currently in Phase 3 development for Non-small cell lung cancer with EGFR mutations (likely primary indication based on drug class). Also known as: gefitinib, Recombinant human endostatin.
This drug inhibits tyrosine kinase activity of the epidermal growth factor receptor (EGFR), blocking downstream signaling that drives cancer cell proliferation.
EGFR-TK Inhibitors are small molecule drugs that target the epidermal growth factor receptor tyrosine kinase, and they are primarily used to treat Non-Small Cell Lung Cancer, particularly in patients with EGFR mutations. These inhibitors have been studied in clinical trials for various indications, including Non-Small Cell Lung Cancer with EGFR mutation and brain metastases.
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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-TK Inhibitor |
|---|---|
| Also known as | gefitinib, Recombinant human endostatin |
| Sponsor | Xinqiao Hospital of Chongqing |
| Drug class | EGFR tyrosine kinase inhibitor |
| Target | EGFR |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
EGFR-TK inhibitors are small molecules that competitively bind to the ATP-binding pocket of EGFR's intracellular tyrosine kinase domain, preventing autophosphorylation and activation of downstream signaling pathways (such as MAPK and PI3K/AKT). This leads to cell cycle arrest and apoptosis in EGFR-dependent tumors, particularly those with activating EGFR mutations.
Approved indications
- Non-small cell lung cancer with EGFR mutations (likely primary indication based on drug class)
Common side effects
- Rash/acneiform dermatitis
- Diarrhea
- Nausea
- Fatigue
- Interstitial lung disease
Key clinical trials
- Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) (PHASE3)
- Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer (PHASE1)
- Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor (PHASE1)
- Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma (PHASE2)
- Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII (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)
- 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)
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-TK Inhibitor CI brief — competitive landscape report
- EGFR-TK Inhibitor updates RSS · CI watch RSS
- Xinqiao Hospital of Chongqing portfolio CI
Frequently asked questions about EGFR-TK Inhibitor
What is EGFR-TK Inhibitor?
How does EGFR-TK Inhibitor work?
What is EGFR-TK Inhibitor used for?
Who makes EGFR-TK Inhibitor?
Is EGFR-TK Inhibitor also known as anything else?
What drug class is EGFR-TK Inhibitor in?
What development phase is EGFR-TK Inhibitor in?
What are the side effects of EGFR-TK Inhibitor?
What does EGFR-TK Inhibitor target?
Related
- Drug class: All EGFR tyrosine kinase inhibitor drugs
- Target: All drugs targeting EGFR
- Manufacturer: Xinqiao Hospital of Chongqing — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer with EGFR mutations (likely primary indication based on drug class)
- Also known as: gefitinib, Recombinant human endostatin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing