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.

health-canada-dpdRegulatory14 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as NAT-ERLOTINIB (DIN 02483939) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Dec 1, 2021	May 8, 2019	health-canada-dpd
CA Health Canada	—	Marketed in Canada as NAT-ERLOTINIB (DIN 02483920) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Oct 1, 2021	May 8, 2019	health-canada-dpd
CA Health Canada	—	Marketed in Canada as NAT-ERLOTINIB (DIN 02483912) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormant

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 17 hours 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 251–268 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
EGFR L861Q1
Erlotinib + Gefitinib

Clinical trials

Trials with this intervention (401)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 301–350 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
NCT01342965	A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations	completed	Phase 3	217	Hoffmann-La RocheINDUSTRY	3	Feb 24, 2015	clinicaltrials
NCT00556322	A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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 20 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 R831H1

Erlotinib

Malignant NeoplasmALIAS

Predictive

Supports Sensitivity Response

accepted

EID4279

In an in vitro study performed after identification of the mutation in a malignant peritoneal mesothelioma patient, COS-7 cells expressing EGFR R831H demonstrated increased EGFR phosphotyrosine after … (full text at CIViC)

PMID 20942962 · Foster et al., 2010 · Open in CIViC

KRAS Exon 2 Mutation2
Erlotinib + GemcitabineCombination	Malignant Pancreatic Neoplasm	Predictive	B	Supports Resistance	4	accepted	EID1219 In a retrospective study of 136 pancreatic cancer patients, point mutations in KRAS exon 2 were associated with worse overall survival compared to that of wild-type KRAS (5.8 vs 8.0 months; P = 0.001;… (full text at CIViC) PMID 21862683 · Kim et al., 2011 · Open in CIViC	civic
Erlotinib	Pancreatic Carcinoma	Predictive	B	Does Not Support Resistance	3	accepted	EID916 KRAS exon 2 was mutated in 121 of 173 (70%) patients with advanced pancreatic cancer and did not show an association with response to erlotinib treatment. PMID 23435671 · Boeck et al., 2013 · Open in CIViC	civic