TheraRadar
Data updated: May 26, 2026

ERLOTINIB HYDROCHLORIDE

Genetically Validated
Oncology Approved 2014-06-11

ERLOTINIB HYDROCHLORIDE is indicated for the treatment of Non-Small Cell Lung Cancer; Pancreatic Cancer.

Source: FDA Label • Teva
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ERLOTINIB HYDROCHLORIDE Works

Erlotinib reversibly inhibits the kinase activity of the epidermal growth factor receptor (EGFR) on the surface of both normal and cancer cells. By preventing the autophosphorylation of tyrosine residues associated with the receptor, it blocks downstream signaling pathways that facilitate tumor cell survival and proliferation. The drug exhibits a higher binding affinity for EGFR exon 19 deletion or exon 21 (L858R) mutations compared to the wild-type receptor.

Source: FDA Label
11
Indications
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2014-06-11
Routes
ORAL
Dosage Forms
TABLET

Companies

Teva ZYDUS PHARMS NATCO PHARMA LTD HETERO LABS LTD V Sun Pharma ACCORD HLTHCARE SHILPA ALEMBIC EUGIA PHARMA MSN Apotex RISING CHARTWELL RX
Active Ingredient: ERLOTINIB HYDROCHLORIDE

ERLOTINIB HYDROCHLORIDE Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
50 FDA actions from 2014 to 2024
Sep 2024 ORIGINAL
Update
May 2024 ORIGINAL
Update
Jun 2022 ORIGINAL
Update

What ERLOTINIB HYDROCHLORIDE Treats

2 indications

ERLOTINIB HYDROCHLORIDE is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Non-Small Cell Lung Cancer
  • Pancreatic Cancer
Source: FDA Label

ERLOTINIB HYDROCHLORIDE Target & Pathway

Pro

Target

EGFR (Epidermal Growth Factor Receptor) Growth Factor Receptor

A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.

ERLOTINIB HYDROCHLORIDE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

10

Same target(s) AND same indication — head-to-head.

RYBREVANT FASPRO
Johnson &
2025 1 indic.
HYRNUO
Bayer
2025 1 indic.

MoA expansion candidates

5

Same target(s), different indications — where else is this mechanism being explored?

NERLYNX
PUMA BIOTECH
2017 1 indic.
CAPRELSA
Sanofi
2011 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

AVOPEF
AVYXA HOLDINGS
2026 2 indic.
KEYTRUDA QLEX
Merck
2025 2 indic.
Unlock 19 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ERLOTINIB HYDROCHLORIDE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AVGEMSI
GEMCITABINE HYDROCHLORIDE
2 shared
AVYXA HOLDINGS
Shared indications:
Non-Small Cell Lung CancerPancreatic Cancer
GEMCITABINE HYDROCHLORIDE
GEMCITABINE HYDROCHLORIDE
2 shared
Teva
Shared indications:
Non-small cell lung cancerPancreatic cancer
ALECENSA
ALECTINIB HYDROCHLORIDE
1 shared
Roche
Shared indications:
Non-Small Cell Lung Cancer
View all 20 similar drugs Pro
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Clinical Trial Registry

64 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
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
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
NCT00660816 results posted CASE2507 P30CA043703, CASE2507 Ph 2 completed Pemetrexed or Docetaxel With or Without Erlotinib in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT02134886 NCI-2014-00684 NCI-2014-00684, AMC-090 Ph 1 terminated Erlotinib Hydrochloride in Treating Non-Small Cell Lung Cancer That is Metastatic or Cannot be Removed by Surgery in Patients With HIV Infection

Showing 50 of 64 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

ERLOTINIB HYDROCHLORIDE FDA Label Details

Indications & Usage

ERLOTINIB HYDROCHLORIDE is indicated for the treatment of Non-Small Cell Lung Cancer; Pancreatic Cancer.

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Data Sources

FDA Approval: ANDA091059 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.