Data updated: May 26, 2026
TARCEVA (erlotinib hydrochloride)
Trial Activity: Declining 7 active trials
Oncology
Approved 2004-11-18
Development Insights
National Cancer Institute (NCI) conducting 22 trials (31%)
213 indications explored (Broad Platform)
→ lung cancer (9 trials)
→ stage iv non-small cell lung cancer (8 trials)
→ pancreatic cancer (7 trials)
9
Indications
--
Phase 3 Trials
4
Priority Reviews
21
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2004-11-18
- Routes
- ORAL
- Dosage Forms
- TABLET
TARCEVA Approval History
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
57 FDA actions from 2004 to 2016 · 8 indication expansions
Mar 2016 SUPPL Priority
Mfg
Jul 2015 SUPPL Priority
Mfg
What TARCEVA Treats
9 FDA approvalsOriginally approved for its first indication in 2004 . Covers 9 distinct patient populations.
- Other (9)
Other
(9 approvals)- • Approved indication (Nov 2004) PriorityLabel Letter
- • Approved indication (Nov 2005) PriorityLabel Letter
- • Approved indication (Sep 2008)Label Letter
- • Approved indication (Apr 2010)Label Letter
- • Approved indication (May 2013) PriorityLabel Letter
- • Approved indication (Apr 2015) PriorityLabel Letter
- • Approved indication (May 2016)Label Letter
- • Approved indication (Jun 2016)Label Letter
- • Approved indication (Oct 2016)Label Letter
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Clinical Trial Registry
70 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06997068 | MC240701 24-009083 | Ph 2 | recruiting | Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Head and Neck Cancer in a Rural Midwest United States Population |
| NCT02193282 | NCI-2014-01508 NCI-2014-01508, s16-02079 | Ph 3 | active not recruiting | Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial) |
| NCT01708954 results posted | NCI-2012-01938 NCI-2012-01938, ECOG-E1512 | Ph 2 | active not recruiting | Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer |
| NCT04172779 ECHO-B | STU-2019-1515 P50CA295495 | Ph 2 | not yet recruiting | Erlotinib for Hepatocellular Carcinoma Chemoprevention |
| NCT00885066 | 2007/36 CALACASS-CAPERGEM, ROCHE-CALACASS-CAPERGEM | Ph 1 | completed | Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer |
| NCT01660971 | NCI-2012-01290 NCI-2012-01290, VICCGI1173 | Ph 1 | active not recruiting | Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery |
| NCT00878163 | NCI-2011-01400 NCI-2011-01400, CDR0000638302 | Ph 1 | active not recruiting | GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery |
| NCT01013649 results posted | NCI-2011-01987 NCI-2011-01987, 11-00773 | Ph 3 | completed | Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery |
| NCT03137771 results posted | NRG-LU002 NCI-2016-00849, NRG-LU002 | Ph 2 | active not recruiting | Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer |
| NCT00954226 | 2008-0137 NCI-2012-01639, NCI-2010-01142 | Ph 1 | completed | Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer |
| NCT02535338 results posted | NCI-2015-01411 NCI-2015-01411, PHI-80 | Ph 1, Ph 2 | completed | Erlotinib Hydrochloride and Onalespib Lactate in Treating Patients With Recurrent or Metastatic EGFR-Mutant Non-small Cell Lung Cancer |
| NCT01064479 results posted | 2009-0395 NCI-2011-03782, 2009-0395 | Ph 2 | completed | Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck |
| NCT02273362 results posted | NCI-2014-02170 NCI-2014-02170, HHSN261201200042I | Ph 1, Ph 2 | completed | Erlotinib Hydrochloride in Preventing Liver Cancer in Patients With Cirrhosis of the Liver |
| NCT01068587 | I196 CAN-NCIC-IND196, GSK-CAN-NCIC-IND196 | Ph 1, Ph 2 | completed | MET/VEGFR2 Inhibitor GSK1363089 and Erlotinib Hydrochloride or Erlotinib Hydrochloride Alone in Locally Advanced or Metastatic NSCLC That Has Not Responded to Previous Chemotherapy |
| NCT01332279 | OER-HN-038 | Ph 1 | withdrawn | Everolimus, Erlotinib Hydrochloride, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer Previously Treated With Radiation Therapy |
| NCT02961374 results posted | NCI-2016-01674 NCI-2016-01674, N01-CN-2012-00042 | Ph 2 | completed | Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer |
| NCT00617708 results posted | NCI-2009-00797 NCI-2009-00797, CDR0000586427 | Ph 1, Ph 2 | completed | S0727 Gemcitabine Hydrochloride and Erlotinib Hydrochloride With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery |
| NCT01911507 | 435021 UCDCC#238, P30CA093373 | Ph 1 | completed | INC280 and Erlotinib Hydrochloride in Treating Patients With Non-small Cell Lung Cancer |
| NCT00888511 TARLAL results posted | 09.02 | Ph 2 | completed | Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer |
| NCT01532089 results posted | RC1126 NCI-2012-00053, 11-006881 | Ph 2 | completed | Erlotinib Hydrochloride With or Without Bevacizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations |
| NCT00749892 results posted | 2007-0704 NCI-2018-01833, 2007-0704 | Ph 2 | completed | Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer |
| NCT01222689 results posted | NCI-2011-01266 NCI-2011-01266, CDR0000686634 | Ph 2 | completed | Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer |
| NCT01857271 EVENT results posted | 2013-233 NCI-2013-02219, 2013-233-004 | Ph 2 | terminated | Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer |
| NCT02169284 results posted | NCI-2014-01320 NCI-2014-01320, HHSN261201200033I | Ph 2 | terminated | Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery |
| NCT01192815 results posted | CASE2309 NCI-2010-01885 | Ph 2 | terminated | Erlotinib Hydrochloride and Radiation Therapy in Stage III-IV Squamous Cell Cancer of the Head and Neck |
| NCT02926638 results posted | S1400E NCI-2014-01382, S1400E | Ph 2, Ph 3 | terminated | Lung-MAP: Rilotumumab and Erlotinib Hydrochloride or Erlotinib Hydrochloride Alone as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches |
| NCT00661193 results posted | CDR0000593575 S0709, U10CA032102 | Ph 2 | completed | S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer |
| NCT01664897 results posted | 2012-0060 NCI-2012-02073, 2012-0060 | Ph 2 | completed | Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT00733746 results posted | ACOSOG-Z5041 ACOSOG-Z5041, U10CA076001 | Ph 2 | completed | Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery |
| NCT01259089 results posted | NU 10L01 STU00038215 | Ph 1, Ph 2 | completed | Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer |
| NCT01866410 results posted | NCI-2013-01085 NCI-2013-01085, PHII-125 | Ph 2 | completed | Cabozantinib-S-Malate and Erlotinib Hydrochloride in Treating Patients With Previously Treated Metastatic Non-Small Cell Lung Cancer |
| NCT00940316 results posted | NU 07I4 STU00004101, OSI 4263s | Ph 2 | completed | Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer |
| NCT00573989 results posted | IRB00003457 P30CA012197, CCCWFU-60107 | Ph 1, Ph 2 | terminated | Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck Cancer |
| NCT01688973 results posted | NCI-2012-01641 NCI-2012-01641, S1107 | Ph 2 | completed | Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery |
| NCT00733408 results posted | 6628 NCI-2010-00041, 6628 | Ph 2 | completed | Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer |
| NCT00720356 results posted | NU 07C3 NU 07C3, BTTC08-01 | Ph 2 | completed | Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma |
| NCT01592383 results posted | 12-0032 NCI-2012-00332 | Ph 2 | completed | Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma |
| NCT01103375 | IRB00012306 NCI-2010-00132, CCCWFU 91209 | Ph 1 | terminated | Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma |
| NCT01316757 | FER-HN-027 NCI-2011-00272, P30CA006927 | Ph 2 | completed | Carboplatin, Paclitaxel, Cetuximab, and Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer |
| NCT00553462 results posted | CALGB-30605 CALGB-30605, CDR0000573832 | Ph 2 | completed | Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery |
| NCT01344824 results posted | LCCC 0825 P30CA016086 | Ph 2 | completed | Carboplatin, Pemetrexed Disodium, and Bevacizumab for Patients With Stage III or IV Non-Small Cell Lung Cancer Who Are Light/Never Smokers |
| NCT00881751 results posted | 101282 MUSC-101282, GENENTECH-AVF4481s | Ph 2 | completed | Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer |
| NCT01531712 | ICO-20431 2010-021872-27, GEMERLOXA | Ph 2 | terminated | Study of Neoadjuvant Treatment in Patients With Pancreatic Cancer That is Potentially Resectable |
| NCT00987766 | VICC GI 0906 P30CA068485 | Ph 1 | completed | Gemcitabine Hydrochloride, Oxaliplatin, and Erlotinib Hydrochloride in Treating Patients With Advanced Biliary Tract Cancer, Pancreatic Cancer, Duodenal Cancer, or Ampullary Cancer |
| NCT00550836 results posted | NCCTG-N064B NCI-2009-01089, CDR0000571863 | Ph 2 | completed | Erlotinib and Gemcitabine With or Without Panitumumab in Treating Patients With Metastatic Pancreatic Cancer |
| NCT01294306 results posted | NCI-2011-02578 NCI-2011-02578, CDR0000695056 | Ph 2 | completed | MK2206 and Erlotinib Hydrochloride in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Progressed After Previous Response to Erlotinib Hydrochloride Therapy |
| NCT01839955 | CASE8512 NCI-2013-00599 | Ph 1 | completed | Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer |
| NCT01515969 | IRB-21659 IRB-18952, LUN0044 | Ph 1 | terminated | Phase 1 Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer (NSCLC) |
| NCT00634725 | CDR0000589283 GERCOR-LAP-07-D07-1, EU=20827 | Ph 3 | completed | Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery |
| NCT00738881 MARVEL results posted | NCI-2009-00663 NCI-2009-00663, CDR0000612010 | Ph 3 | terminated | Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer |
Showing 50 of 70 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TARCEVA FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment