NDAORALTABLETPriority Review
Approved
Nov 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
TARCEVA (erlotinib hydrochloride) by Lavipharm is (egfr) is expressed on the cell surface of both normal and cancer cells. First approved in 2004.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TARCEVA (erlotinib hydrochloride) is an oral small-molecule tyrosine kinase inhibitor that reversibly blocks EGFR signaling, preventing autophosphorylation and downstream proliferation in cancer cells. It is primarily used to treat non-small cell lung cancer (NSCLC) and pancreatic cancer, with enhanced binding affinity for EGFR exon 19 deletion and L858R mutations. The drug works by selectively inhibiting tyrosine kinase activity at the receptor level, blocking a key survival pathway in both wild-type and mutant EGFR-expressing tumors.
LOE Approaching
Moderate competitive pressure (30/100) signals declining market opportunity; sales and commercial teams face headwinds as LOE approaches and generic/biosimilar competition intensifies.
Mechanism of Action
(EGFR) is expressed on the cell surface of both normal and cancer cells. In some tumor cells signaling through this receptor plays a role in tumor cell survival and proliferation irrespective of EGFR mutation status. Erlotinib reversibly inhibits the kinase activity of EGFR, preventing…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Tarceva vs. Avastin+Tarceva for Advanced NSCLC With EGFR m(+)
Started Nov 2016
128 enrolled
EGFR Positive Non-small Cell Lung Cancer
Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva)
Started Nov 2014
39 enrolled
Advanced Non Small Cell Lung CancerAdvanced (Inoperable) Non Small Cell Lung Cancer
A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib)
Started Apr 2014
172 enrolled
Non-Small Cell Lung Cancer
My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors
Started Apr 2014
673 enrolled
NeoplasmsSolid TumorsBiliary Cancer+2 more
A Study of the Efficacy and Safety of MetMAb Combined With Tarceva in Patients With Met-Positive Non-Small Cell Lung Cancer
Started Jan 2014
530 enrolled
Non-Small Cell Lung Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.