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Active Comparator (erlotinib)
Active Comparator (erlotinib) is a EGFR tyrosine kinase inhibitor Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Metastatic non-small cell lung cancer with EGFR mutations, Locally advanced or metastatic pancreatic cancer (in combination with gemcitabine).
Erlotinib is a tyrosine kinase inhibitor that blocks epidermal growth factor receptor (EGFR) signaling to inhibit cancer cell proliferation.
Erlotinib is a small molecule inhibitor of the epidermal growth factor receptor (EGFR) used to treat EGFR-positive non-small cell lung cancer. It is classified as an INHIBITOR and works by inhibiting the EGFR erbB1.
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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. -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Active Comparator (erlotinib) |
|---|---|
| Sponsor | Pfizer |
| Drug class | EGFR tyrosine kinase inhibitor |
| Target | EGFR (epidermal growth factor receptor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Erlotinib selectively inhibits the intracellular tyrosine kinase domain of EGFR, preventing autophosphorylation and downstream signaling through the MAPK and PI3K/AKT pathways. This leads to cell cycle arrest and apoptosis in EGFR-dependent tumors. It is particularly effective in non-small cell lung cancers harboring activating EGFR mutations.
Approved indications
- Metastatic non-small cell lung cancer with EGFR mutations
- Locally advanced or metastatic pancreatic cancer (in combination with gemcitabine)
Common side effects
- Rash
- Diarrhea
- Nausea
- Vomiting
- Fatigue
- Anorexia
- Dyspnea
- Interstitial lung disease
Key clinical trials
- Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial) (PHASE3)
- Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial) (NA)
- Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in NSCLC Patients Activating EGFR Mutations (PHASE3)
- Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery (PHASE3)
- A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer (PHASE3)
- A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations (PHASE2)
- AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (PHASE3)
- Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung 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:
- Active Comparator (erlotinib) CI brief — competitive landscape report
- Active Comparator (erlotinib) updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Active Comparator (erlotinib)
What is Active Comparator (erlotinib)?
How does Active Comparator (erlotinib) work?
What is Active Comparator (erlotinib) used for?
Who makes Active Comparator (erlotinib)?
What drug class is Active Comparator (erlotinib) in?
What development phase is Active Comparator (erlotinib) in?
What are the side effects of Active Comparator (erlotinib)?
What does Active Comparator (erlotinib) target?
Related
- Drug class: All EGFR tyrosine kinase inhibitor drugs
- Target: All drugs targeting EGFR (epidermal growth factor receptor)
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic non-small cell lung cancer with EGFR mutations
- Indication: Drugs for Locally advanced or metastatic pancreatic cancer (in combination with gemcitabine)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing