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 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TYKERB (lapatinib) is an oral small-molecule tyrosine kinase inhibitor targeting HER2 and EGFR, approved in 2007 for HER2-positive breast cancer. It is administered as a tablet and represents a foundational dual-kinase inhibitor in the oncology space that has been used in combination with chemotherapy and hormonal agents.
$2MPart D
LOE ApproachingDeclining
3.0 years to LOEWith only $2M in Part D spending and significant competitive pressure (8/10), TYKERB is in late-stage commercialization with contracted team size and focus shifting to managed care and retention rather than growth.
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
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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.