BLAINJECTIONINJECTABLEPriority Review
Approved
Dec 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 21h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENHERTU (fam-trastuzumab deruxtecan-nxki) is an antibody-drug conjugate (ADC) developed by Daiichi Sankyo and approved by the FDA on December 20, 2019. It is indicated for multiple solid tumors and hematologic malignancies including HER2-positive breast cancer, gastric cancer, non-small cell lung cancer, non-Hodgkin lymphoma, and multiple myeloma. The mechanism combines HER2-targeting trastuzumab with a cytotoxic payload delivered via a linker technology. ENHERTU represents an important advance in targeted oncology, enabling treatment of HER2-expressing cancers with improved efficacy and tolerability compared to earlier-generation HER2-directed therapies.
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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 (14)
Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)
Started Mar 2025
582 enrolled
Ovarian Cancer
Castrate Resistant Prostate Cancer Enhertu Therapy
Started Mar 2025
60 enrolled
Prostate Cancer MetastaticProstate CancerCRPC
Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
Started Feb 2025
260 enrolled
HER2-positive Gastric CancerHER2-positive Gastroesophageal Junction
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
Started Dec 2023
250 enrolled
Breast Cancer
Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction
Started Jul 2023
1 enrolled
Esophageal AdenocarcinomaEsophageal CancerHER-2 Protein Overexpression+1 more
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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.