BLAINJECTIONINJECTABLEPriority Review
Approved
Dec 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
6/8 — Strong
Priority Review
ENHERTU (fam-trastuzumab deruxtecan-nxki) by Daiichi Sankyo is fam-trastuzumab deruxtecan-nxki is a her2-directed antibody-drug conjugate. Approved for metastatic her2-positive (ihc 3+, the neoadjuvant, adjuvant setting and 6 more indications. First approved in 2019.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENHERTU (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody-drug conjugate combining a humanized anti-HER2 IgG1 with a topoisomerase I inhibitor payload (DXd). It treats HER2-positive and HER2-low metastatic breast cancer, as well as adjuvant and neoadjuvant settings, by delivering cytotoxic cargo intracellularly following HER2 binding and internalization.
$0.01BPart D
PeakENHERTU is in peak commercial phase with moderate competitive pressure (score: 30/100), indicating mature market positioning and stable, specialized team requirements.
Mechanism of Action
Fam-trastuzumab deruxtecan-nxki is a HER2-directed antibody-drug conjugate. The antibody is a humanized anti-HER2 IgG1. The small molecule, DXd, is a topoisomerase I inhibitor attached to the antibody by a cleavable linker. Following binding to HER2 on tumor cells, fam-trastuzumab deruxtecan-nxki…
Indications (8)
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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.