Erlotinib
Small molecule targets EGFR, ERBB2, JAK2, SYK via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | TARCEVA | — | 2005-11-02 – 2016-10-18 | fda.gov ↗ |
| Approved | EU (EMA) | Tarceva | — | 2005-09-19 | europa.eu ↗ |
| Approved | US (FDA) | TARCEVA | — | 2004-11-18 | fda.gov ↗ |
Trials 610 · started per year
Press releases naming this drug 14 releases
Evidence & citations 25 cited values
Every value below carries the sentence it was read from. 759 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | erlotinib | “Tivantinib 360 mg twice daily in combination with other anti-cancer therapy (eg, erlotinib,sorafenib, pemetrexed, docataxel, gemcitabine, irinotecan, and/or cetuximab) at the...” NCT01178411 ↗698“Carboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine, vinorelbine, pemetrexed, or erlotinib administered on Day 1 of every 21-day cycle except gemcitabine, which was...” NCT00312728 ↗ “Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil,...” NCT01505530 ↗ “GEMOX-Erlotinib consists of erlotinib 100 mg orally daily starting day 1, Gemcitabine 1000 mg/m2 in 10 mg/m2/min (100 minutes) infusion on day 1 followed on day 2 by...” NCT00636883 ↗ “Patients were randomly allocated to receive EGFR-TKIs (erlotinib hydrochloride, afatinib dimaleate, or gefitinib at standard dosage) plus metformin hydrochloride (500 mg twice...” PMID 31486833 ↗ Nov 2019 “To assess the clinical efficacy, biologic effects and safety of the EGFR inhibitor erlotinib in the treatment of patients with 'triple receptor-negative' metastatic carcinoma...” NCT00739063 ↗ “Patients with advanced solid malignancies were administered oral tivantinib at escalating doses of 120, 240, 360, and 480 mg twice daily (BID) plus 150 mg erlotinib once daily (QD).” PMID 22605616 ↗ May 2012 “Investigator's choice of one of the following commercially available products: gemcitabine; capecitabine; fluorouracil with or without leucovorin; irinotecan; or erlotinib.” NCT02004262 ↗ “Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib” NCT07802418 ↗ “Erlotinib is administered 150 mg once per day , or Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity.” NCT04007835 ↗ “COX-2 inhibitor Celecoxib and EGFR tyrosine kinase inhibitor Erlotinib alone or in combination on molecular markers of apoptosis and angiogenesis.” NCT02748707 ↗ |
| Known as | CP-358 | ChEMBL registry synonym — accepted as the source's own label CHEMBL553 ↗ |
| Known as | CP-358,774 | “Erlotinib, CP-358,774, erlotinib hydrochloride” NCT01471964 ↗ |
| Known as | CP-358,774-01 | ChEMBL registry synonym — accepted as the source's own label CHEMBL553 ↗ |
| Known as | ERL | “Patients received three cycles of GEM (1000 mg/m2/week) plus daily erlotinib (ERL) (100 mg/day).” PMID 30225601 ↗ Sep 2018 |
| Known as | Erlotinib (OSI-774) | “Erlotinib (OSI-774)” NCT00983307 ↗ |
| Known as | erlotinib - Tarceva - OSI-774 | “Erlotinib :- Tarceva™ (OSI-774)” NCT00996515 ↗1“erlotinib - Tarceva - OSI-774” NCT00672243 ↗ |
| Known as | Erlotinib chlorhydrate | “There are three cohorts of patients in whom the dose of Erlotinib chlorhydrate(100 and 150 mg) and Cisplatin (30 and 40 mg / m2) will be increase, and the doses of Radiation...” NCT00442455 ↗ |
| Known as | Erlotinib HCl | “Tarceva (Trademark) (erlotinib HCl, OSI-774)” NCT00072631 ↗14“Tarceva (Trademark) (erlotinib HCl, OSI-774)” NCT00085839 ↗ “oral erlotinib HCl 150 mg/day orally” NCT00130728 ↗ “Tarceva (erlotinib HCl, OSI-774 )” NCT00036647 ↗ “Tarceva (erlotinib HCl, OSI-774)” NCT00040183 ↗ “Drug: Erlotinib HCl 150 mg” NCT04145570 ↗ “Erlotinib HCl (OSI-774)” NCT00109265 ↗ “Tarceva (erlotinib HCl)” NCT00095225 ↗ “Tarceva (erlotinib HCl)” NCT00091663 ↗ “Tarceva (erlotinib HCl)” NCT00081614 ↗ “Tarceva (erlotinib HCl)” NCT00047736 ↗ |
| Known as | erlotinib hydrochloride | “To characterize the safety and tolerability of the combination of erlotinib (erlotinib hydrochloride) and dovitinib (dovitinib lactate), assessing for toxicity using the Common...” NCT01515969 ↗98“Phase I Studies of TARCEVA™ (ERLOTINIB HYDROCHLORIDE, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With...” NCT00360854 ↗ “erlotinib (erlotinib hydrochloride) doses as low as 25 mg will decrease aberrant crypt foci (ACF) phosphorylated extracellular signal-regulated kinases (pERK) levels from...” NCT00754494 ↗ “OBJECTIVES: Primary * Determine overall survival of patients with stage IIIB or IV bronchioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features treated with...” NCT00436332 ↗ “Patients were randomly allocated to receive EGFR-TKIs (erlotinib hydrochloride, afatinib dimaleate, or gefitinib at standard dosage) plus metformin hydrochloride (500 mg twice...” PMID 31486833 ↗ Nov 2019 “Patients also receive oral erlotinib hydrochloride once daily beginning on day 1 of radiotherapy and continuing for up to 2 years in the absence of disease progression or...” NCT00573989 ↗ “Patients receive vinflunine IV over 20 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-21 of course 1 and on days 1-21 of all subsequent courses.” NCT00320073 ↗ “Tarceva (erlotinib hydrochloride; previously referred to as OSI-774), a quinazoline, is an orally active, potent, selective inhibitor of EGFR tyrosine kinase.” NCT00187486 ↗ “Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival.” NCT00543842 ↗ “Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival.” NCT01180959 ↗ “Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.” NCT00976677 ↗ |
| Known as | Erlotinib: Tarceva | “Erlotinib: Tarceva®” NCT00585377 ↗3“Erlotinib - Tarceva” NCT00709826 ↗ “erlotinib (Tarceva)” NCT01116219 ↗ “erlotinib (Tarceva)” NCT02321293 ↗ |
| Known as | NSC-718781 | “A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and...” NCT00436332 ↗2“A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas” NCT00445848 ↗ “OSI-774 (Erlotinib; NSC-718781)” NCT00661193 ↗ |
| Known as | OSI-774 | “A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and...” NCT00436332 ↗26“Phase I Studies of TARCEVA™ (ERLOTINIB HYDROCHLORIDE, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With...” NCT00360854 ↗ “A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas” NCT00445848 ↗ “OSI-774 (also known as Erlotinib or Tarceva) is a drug that helps to block the activity of an enzyme that is believed to play an important role in cell growth.” NCT00113347 ↗ “Tarceva (erlotinib hydrochloride; previously referred to as OSI-774), a quinazoline, is an orally active, potent, selective inhibitor of EGFR tyrosine kinase.” NCT00187486 ↗ “HNSCC patients treated in three escalating dose cohorts of daily continous oral erlotinib (OSI-774) and intermittent IV cisplatin given every 21 days” NCT00030576 ↗ “TarcevaTM (Erlotinib Hydrochloride, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors” NCT00418327 ↗ “A Phase I Study of BAY 43-9006 (Sorafenib) in Combination With OSI-774 (Erlotinib; Tarceva) in Advanced Solid Tumors” NCT00126620 ↗ “Erlotinib (Tarceva, OSI-774) can be safely used up to a dose of 150 mg two times a day for 12 months” NCT00301418 ↗ “Erlotinib (OSI-774, Tarceva) is an orally available inhibitor of human EGFR tyrosine kinase.” NCT00459901 ↗ “an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva)” NCT00243854 ↗ |
| Known as | R-1415 | ChEMBL registry synonym — accepted as the source's own label CHEMBL553 ↗ |
| Known as | RG-1415 | ChEMBL registry synonym — accepted as the source's own label CHEMBL553 ↗ |
| Known as | Ro-508231 | ChEMBL registry synonym — accepted as the source's own label CHEMBL553 ↗ |
| Known as | Tarceva | “This randomized, Phase III, double-blind, placebo-controlled study will evaluate the safety and efficacy of MetMAb (onartuzumab) in combination with Tarceva (erlotinib)...” NCT02031744 ↗107“This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer...” NCT01260181 ↗ “Erlotinib (Tarceva®)is an oral inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase and its anti-neoplastic effect is approved especially women, patients with...” NCT01130753 ↗ “Phase I Studies of TARCEVA™ (ERLOTINIB HYDROCHLORIDE, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With...” NCT00360854 ↗ “The purpose of this study is to determine whether Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib (Tarceva) is effective in the treatment of unresectable, metastatic...” NCT01149122 ↗ “Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression...” NCT00605722 ↗ “A Randomized, Open-Label Phase II Clinical Trial of Combination Erlotinib (Tarceva®) and Fulvestrant (Faslodex®) Versus Erlotinib (Tarceva®) Alone in Advanced Non-Small Cell...” NCT00100854 ↗ “The purpose of this study is to learn about the effects of two new anticancer drugs, erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung cancer.” NCT00125359 ↗ “The main purpose of this research study is to see if adding fulvestrant (Faslodex) to erlotinib (Tarceva) is effective in patients with stage IIIb/IV Non-Small Cell Lung Cancer.” NCT00592007 ↗ “The Federal Drug Administration (FDA) has approved erlotinib, also known as Tarceva, for the treatment of locally advanced and metastatic non-small cell lung cancer.” NCT00597597 ↗ “OSI-774 (also known as Erlotinib or Tarceva) is a drug that helps to block the activity of an enzyme that is believed to play an important role in cell growth.” NCT00113347 ↗ |
| Known as | Tarceva (Trademark) | “Tarceva (Trademark) (erlotinib HCl, OSI-774)” NCT00072631 ↗1“Tarceva (Trademark) (erlotinib HCl, OSI-774)” NCT00085839 ↗ |
| Known as | Tarceva(TM) (erlotinib) | “Tarceva(TM) (erlotinib)” NCT00602667 ↗ |
| Known as | TarcevaTM | “Inhibition of kinase function of EGFR by approved inhibitor Erlotinib (TarcevaTM) broadly inhibits HCV infection of all major genotypes including viral escape variants...” NCT01835938 ↗2“Erlotinib (TarcevaTM) is a newer drug which has shown benefit for patients with lung cancers that contain an EGFR mutation.” NCT00577707 ↗ “OSI-774: erlotinib, TarcevaTM” NCT00590902 ↗ |
| Known as | USAN: erlotinib hydrochloride | “USAN: erlotinib hydrochloride” NCT00054275 ↗ |
| Action | Inhibit | “selective inhibitor of EGFR tyrosine kinase activity” PMID 18591547 ↗ Jun 2008 |
| Modality | Small molecule | “Sorafenib and erlotinib are potent, orally administered receptor tyrosine kinase inhibitors with antiproliferative and antiangiogenic activities.” PMID 17699864 ↗ Aug 2007 |
| Route | Oral | “100 or 150 mg/d orally” PMID 17452677 ↗ Apr 2007 |
| Target | EGFR | “HER1/EGFR-targeted agent” PMID 17452677 ↗ Apr 2007 |