Drug · Small Molecule

Erlotinib

CI-DRUG-00000223Explore in graph →NCIt C65530 CHEMBL553 CIViC Approved

Regulatory

Approvals (23)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	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.	approved	Sep 19, 2005	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	12	6	51	389	23	CA, EU, US	Sep 19, 2005	2001-05
Malignant Lung Neoplasm	Approved	Phase 4	6	1	38	211	4	US	Aug 28, 2015	2004-04
Malignant Pancreatic Neoplasm	Approved	Phase 4	1	1	2	31	2	US	Aug 28, 2015	2005-07
Malignant Kidney Neoplasm	Phase4	Phase 4	1	1	0	7	0

Curated evidence

Clinical evidence (268)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–50 of 268 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ERRFI1 E384*2
Erlotinib	Cholangiocarcinoma

Clinical trials

Trials with this intervention (401)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 401 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02194738	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)	active not recruiting	N/A	7,458	National Cancer Institute (NCI)NIH	3	Sep 23, 2026	clinicaltrials
NCT04981509	Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer

Molecule

Record

Kind: Small Molecule
Mechanism: Epidermal growth factor receptor erbB1 inhibitor
Targets: 1 gene
UNII: DA87705X9K
Aliases: APO-ERLOTINIB, CP-358,774, CP-358774, CP-35877401, Erlotinib, Erlotinib Hydrochloride, ERLOTINIB HYDROCHLORIDE, NAT-ERLOTINIB, PMS-ERLOTINIB, R-1415, RG-1415, Ro-508231, TARCEVA, TEVA-ERLOTINIB

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (30)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EB02	ERLOTINIB
DIN (Health Canada)	02269007	TARCEVA
DIN (Health Canada)

EGFR G598V2
Afatinib + Erlotinib + OsimertinibSubstitutes	GlioblastomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	submitted	EID8234 Patient-derived GBM brain tumour stem cells (BTSCs) were used to test the efficacy of EGFR inhibitors in vitro. Afatinib inhibited the growth and sphere-forming ability of BTSCs but not normal astrocy… (full text at CIViC) PMID 32226941 · Jensen et al., 2020 · Open in CIViC	civic
Erlotinib + PacritinibCombination	GlioblastomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	submitted	EID8236 Patient-derived GBM brain tumour stem cells (BTSCs) were used to test the efficacy of the EGFR inhibitor erlotinib and JAK2 inhibitor pacritinib in vitro. Combination treatment with erlotinib and pacr… (full text at CIViC) PMID 32226941 · Jensen et al., 2020 · Open in CIViC	civic

SEPTIN14 Fusion2
Erlotinib + LapatinibSequential	GlioblastomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID11002 Analysing whole transcriptome data from 185 GBM samples from TCGA, EGFR fusion events were found in 7.6% (14) of the cohort. In 6 of 14 cases, in-frame EGFR::SEPT14 (e24:e10) fusions were detected (3.… (full text at CIViC) PMID 23917401 · Frattini et al., 2013 · Open in CIViC	civic
〃	GlioblastomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	submitted	EID11155 The primary aim of the study was the characterisation of fusion events in 185 GBM samples. As part of this study, a GBM xenograft with EGFR::SEPT14 fusion, derived from a heavily pre-treated patient, … (full text at CIViC) PMID 23917401 · Frattini et al., 2013 · Open in CIViC	civic

EGFR VIII2
Erlotinib + GefitinibSubstitutes	GlioblastomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID1128 Expression of EGFRvIII and PTEN was evaluated in 26 patients with glioblastomas treated with erlotinib or gefitinib and no EGFR or Her2/neu kinase domain mutations. 7 patients responded to treatment w… (full text at CIViC) PMID 16282176 · Mellinghoff et al., 2005 · Open in CIViC	civic
Erlotinib	High-Grade Glioma, NOS	Predictive	D	Supports Sensitivity Response	3	accepted	EID4500 In an in vitro study, a Ba/F3 cell line expressing EGFR vIII demonstrated increased sensitivity to erlotinib treatment, compared to Ba/F3 cells expressing EGFR wild-type. Variant function was assessed… (full text at CIViC) PMID 17177598 · Lee et al., 2006 · Open in CIViC	civic

MAPK1 E322K2
Erlotinib	Head and Neck Squamous Cell Carcinoma	Predictive	C	Supports Sensitivity Response	4	accepted	EID791 Case report of a patient with stage IVA HNSCC with near-complete histologic response after 13 days of neoadjuvant erlotinib. Whole-exome sequencing of the pre-treatment tumor revealed a MAPK1 E322K mu… (full text at CIViC) PMID 26181029 · Van Allen et al., 2015 · Open in CIViC	civic
〃	Head and Neck Squamous Cell Carcinoma	Predictive	D	Supports Sensitivity Response	—	submitted	EID4797 In an in vitro study, a HSC-6 cell line expressing MAPK1 E322K mutation was associated with sensitivity to erlotinib treatment, compared to Cal33 cells expressing wild-type MAPK1. Sensitivity was dete… (full text at CIViC) PMID 27004400 · Wen et al., 2016 · Open in CIViC	civic

EGFR E746_A750del4
Erlotinib	Hematopoietic and Lymphoid Cell NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	—	submitted	EID4208 EGFR E746_A750del mutation has been associated with sensitivity to first generation EGFR tyrosine kinase inhibitors, including erlotinib. In an in vitro study, PC9 cells (EGFR E746_A750del) demonstrat… (full text at CIViC) PMID 24893891 · Cross et al., 2014 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	—	submitted	EID4205 In a Taiwanese stage IV lung adenocarcinoma patient with brain metastasis harboring EGFR E746_A750del mutation, EGFR E746_A750del was reported to be sensitive to erlotinib treatment. The patient was t… (full text at CIViC) PMID 17618013 · Chang et al., 2007 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	—	submitted	EID4206 In lung adenocarcinoma patients with EGFR E746_A750del mutation (n=2), EGFR E746_A750del was associated with improved response to erlotinib treatment. The patients were treated with erlotinib monother… (full text at CIViC) PMID 17085664 · Balak et al., 2006 · Open in CIViC	civic
〃	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	—	submitted	EID4207 In a retrospective study of 46 advanced non-small cell lung cancer patients, two patients harboring EGFR E746_A750del mutation were associated with resistance to erlotinib treatment. One patient survi… (full text at CIViC) PMID 27032107 · De Grève et al., 2016 · Open in CIViC	civic