NDAORALTABLETPriority Review
Approved
Apr 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
28
Data completeness
5/8 — Partial
Priority Review
TUKYSA (tucatinib) by Pfizer is tyrosine kinase inhibitors [moa]. First approved in 2020.
Drug data last refreshed 6m ago · AI intelligence enriched 6h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TUKYSA (tucatinib) is an oral tyrosine kinase inhibitor developed by Pfizer that selectively targets HER2-positive cancers. It works by blocking HER2 protein signaling to inhibit tumor cell growth and division. The drug is indicated for HER2-positive breast cancer and represents a precision oncology approach to kinase-driven malignancies.
$0.102BPart D
Peak11.6 years to LOETUKYSA is in peak commercial phase with $102M Part D spending in 2023 and 4,891 claims, indicating stable oncology franchise support with moderate team size investment.
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 (28)
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
Tucatinib Continuation Study
Started Nov 2026
175 enrolled
HER2-positive Breast CancerCervical CancerBiliary Tract Neoplasms+4 more
Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib
Started Aug 2026
26 enrolled
HER2+ Metastatic Breast Cancer (MBC)
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
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
Worked on TUKYSA at Pfizer? 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.