NDAORALTABLETPriority Review
Approved
Apr 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
27
Data completeness
5/8 — Partial
Priority Review
TUKYSA (tucatinib) by Pfizer is tyrosine kinase inhibitors [moa]. First approved in 2020.
Drug data last refreshed 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TUKYSA (tucatinib) is an oral tyrosine kinase inhibitor that selectively targets HER2, used to treat HER2-positive breast cancer. It works by blocking HER2 signaling pathways that drive cancer cell growth. The drug is administered as an oral tablet and represents a targeted small-molecule approach to oncology.
$0.102BPart D
Peak11.8 years to LOEStrong peak-stage asset with $102M in 2023 Part D spending indicates established market presence and stable commercial team structure.
Mechanism of Action
Tyrosine Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (27)
A Study to Learn More About Tukysa Once it is Out in the Korean Market
Started Jan 2027
600 enrolled
HER2-positive Locally Advanced UnresectableMetastatic Breast Cancer
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
Started May 2026
650 enrolled
HER2-positive Breast Cancer
Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
Started Apr 2026
26 enrolled
HER2+ Metastatic Breast Cancer (MBC)
Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer
Started Jan 2026
20 enrolled
Metastatic Breast Cancer ( HER2 Negative)Unresectable Breast Cancer
Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.
Started May 2025
86 enrolled
Metastatic HER2+ Advanced 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.