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Tarceva (erlotinib)
Tarceva works by blocking the epidermal growth factor receptor, a protein that helps cancer cells grow.
Tarceva (erlotinib) is a small molecule kinase inhibitor originally developed by OSI PHARMS and currently owned by the same company. It targets the epidermal growth factor receptor (EGFR) to inhibit cancer cell growth. Tarceva is approved to treat adenocarcinoma of the pancreas and non-small cell lung cancer. The drug is off-patent, with 13 generic manufacturers available. Key safety considerations include rash, diarrhea, and liver damage.
At a glance
| Generic name | erlotinib |
|---|---|
| Sponsor | Osi Pharms |
| Drug class | Kinase Inhibitor |
| Target | Epidermal growth factor receptor |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2004 |
Mechanism of action
The mechanism of clinical antitumor action of erlotinib is not fully characterized. Erlotinib inhibits the intracellular phosphorylation of tyrosine kinase associated with the epidermal growth factor receptor (EGFR). Specificity of inhibition with regard to other tyrosine kinase receptors has not been fully characterized. EGFR is expressed on the cell surface of normal cells and cancer cells.
Approved indications
- Adenocarcinoma of pancreas
- Non-small cell lung cancer
Common side effects
- Rash
- Diarrhea
- Fatigue
- Nausea
- Cough
- Dyspnea
- Vomiting
- Anorexia
- Asthenia
- Dry skin
- Back pain
- Chest pain
Drug interactions
- dexamethasone
- esomeprazole
- fosphenytoin
- lansoprazole
- nefazodone
- nelfinavir
- omeprazole
- pantoprazole
- phenobarbital
- phenytoin
- primidone
- rifabutin
Key clinical trials
- Erlotinib Hydrochloride and Irinotecan Hydrochloride in Treating Patients With Advanced Solid Tumors (PHASE1)
- Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial (PHASE1)
- Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (PHASE2)
- Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery (PHASE1)
- Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer (PHASE2)
- 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 (PHASE1)
- 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) (PHASE3)
- Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial) (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tarceva CI brief — competitive landscape report
- Tarceva updates RSS · CI watch RSS
- Osi Pharms portfolio CI