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Drug

Erlotinib

Approved · EMA
Emerging researchLate-stage developmentCooling momentum

Also known as Tarceva.

6
Research papers
5
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Clinical trial2026-07-02Results expected Q3 2026 · ClinicalTrials.gov

Epidermal Growth Factor Receptor Inhibition for Keratinopathies

Clinical trial2026-02-03Results expected Q2 2031 · ClinicalTrials.gov

Phase 1 study of erlotinib plus radiation therapy in patients with advanced cutaneous squamous cell carcinoma.

Research2012-11-22International journal of radiation oncology, biology, physics

Approval: Tarceva (EMA)

Regulatory2005-09-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Erlotinib
Aliases & brands
Tarceva
RxNorm CUI
337525
ChEMBL ID
CHEMBL553
UNII
J4T82NDH7E
Regulatory jurisdictions
mhraema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2005-09-19
Latest approval
2005-09-19
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2005-09-19Approval
Approval: Tarceva (EMA)
Indication: Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFRShow full indication

Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy. Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours. Pancreatic cancer Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer. When prescribing Tarceva, factors associated with prolonged survival should be taken into account.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Erlotinib: new safety information
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

195 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
195
registered trials across all phases
LATEST COMPLETION 2026
5
Active studies
2
Recruiting
36
Late-stage (III+)
124
Completed
66
Discontinued
PHASE DISTRIBUTIONn = 195
Early Phase 11Phase 135Phase 1 / 214Phase 2109Phase 2 / 31Phase 326Phase 45Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20102016
Most influential
Recent papers
Journals, researchers & institutions
Top journals
  • BJU international1
  • Clinical lung cancer1
  • Experimental hematology & oncology1
  • Gynecologic oncology1
  • International journal of radiation oncology, biology, physics1
  • JAMA oncology1
Leading researchers
  • Baghdadi TA1
  • Bhatia S1
  • Borger DR1
  • Borghaei H1
  • Boucher D1
  • Brard L1
  • Brown H1
  • Carroll WR1
Leading institutions
free-text, unnormalised
  • Beth Israel Deaconess Medical Center1
  • Catalan Institut of Oncology-Badalona1
  • Dana-Farber Cancer Institute1
  • Dana-Farber/Brigham and Women's Cancer Center1
  • Fox Chase Cancer Center1
  • Hospital Clínico Universitario de Valencia1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.