Erlotinib Hydrochloride — drug

Regulatory

Approvals (4)

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

openfdaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy.	approved	Nov 5, 2019	openfda
US FDA	Lung Non-Small Cell Carcinoma	The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving ﬁrst-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen	approved	Nov 5, 2019	openfda
US FDA	Malignant Pancreatic Neoplasm	First-line treatment of patients with locally advanced, unrespectable or metastatic pancreatic cancer, in combination with gemcitabine.	approved	Nov 5, 2019	openfda
US FDA	Lung Non-Small Cell Carcinoma

Data updated 3 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 3	8	1	14	183	4	US	Nov 5, 2019	Jul 23, 2001
Malignant Lung Neoplasm	Approved	Phase 3	3	0	10	65	2	US	Nov 5, 2019	2001-12
Malignant Pancreatic Neoplasm	Approved	Phase 3	2	0	3	24	1	US	Nov 5, 2019	Jul 23, 2001
Malignant Ovarian Neoplasm	Phase3	Phase 3	0	0	1	6	0

Curated evidence

Clinical evidence (1)

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

civicCuratedShowing 1–1 of 1 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
PTPRF EXPRESSION1
Erlotinib Hydrochloride

Clinical trials

Trials with this intervention (184)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 184 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
NCT00100854	Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer	completed	Phase 2	108	Translational Oncology Research InternationalOTHER	1	Mar 5, 2019	clinicaltrials
NCT00573989	Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck Cancer