NDAORALTABLETPriority Review
Approved
Mar 2007
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
28
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TYKERB (lapatinib) is an oral small-molecule tyrosine kinase inhibitor targeting EGFR and HER2 receptors used to treat HER2-positive breast cancer and other solid tumors. It works by blocking intracellular signaling pathways that drive tumor cell growth and demonstrates activity in trastuzumab-resistant disease. The drug is administered as an oral tablet and is indicated across multiple cancer types including breast, colorectal, head and neck, and lung cancers.
$2MPart D
PeakDeclining
3.4 years to LOEProduct is in mature/declining phase with minimal Medicare claims, suggesting small commercial team and limited growth investment.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (28)
A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib vs Herceptin
Started Mar 2017
482 enrolled
HER2-positive Breast Cancer
Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
Started Oct 2015
10 enrolled
Anemia of Chronic Kidney Disease
Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer
Started Dec 2014
62 enrolled
Cancer
Lapatinib Plus Trametinib in KRAS Mutant NSCLC
Started Oct 2014
35 enrolled
Colorectal Cancer
Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer
Started Sep 2014
20 enrolled
Metastatic Triple Negative Breast Cancer
Worked on TYKERB at Novartis? Share your interview experience or compensation data (+7 days Pro)
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.