BLAINTRAVENOUSVIALPriority Review
Approved
Sep 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
HERCEPTIN (trastuzumab) by Roche is her2/neu/cerbb2 antagonists [moa]. Approved for her2/neu receptor antagonist [epc]. First approved in 1998.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Herceptin (trastuzumab) is a monoclonal antibody that targets the HER2/neu receptor, used to treat HER2-positive breast cancers and gastric cancers. It works by binding to HER2 receptors on cancer cells, blocking growth signals and triggering immune-mediated cell death. This pioneering anti-HER2 therapy has become a standard-of-care component in HER2+ oncology.
$0.004BPart D
LOE ApproachingDeclining
Approaching loss of exclusivity with moderate competitive pressure (30/100) signals team consolidation and shift toward lifecycle management and transition support roles.
Mechanism of Action
HER2/Neu/cerbB2 Antagonists
Pharmacologic Class:
HER2/neu Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Multicenter, Single-Arm, Prospective Phase II Clinical Study of Trastuzumab Rezetecan Combined With Radiotherapy in Patients With HER2-Mutated Oligoprogressive Advanced Non-Small Cell Lung Cancer
Started Aug 2026
30 enrolled
HER2-mutated Advanced Non-small Cell Lung Cancer With Oligoprogression
A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast Cancer
Started Aug 2026
220 enrolled
Hormone Receptor PositiveHER2-low or HER2-ultralowUnresectable or Metastatic Breast Cancer
A Study of Trastuzumab Deruxtecan (T-DXd) and Cetuximab in People With Colorectal Cancer
Started Aug 2026
27 enrolled
Colorectal CancerAdenocarcinoma of the ColonAdenocarcinoma of the Rectum
BEYOND Study: A Multicentre, Prospective, Observational Study of Real-world Treatment Patterns and Outcomes of Trastuzumab Deruxtecan in Patients With HR Positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated With Endocrine Therapy
Started Jul 2026
109 enrolled
Breast Cancer
HER2 Molecular Imaging With 89Zr-trastuzumab PET/CT as a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients With Advanced HER2-positive Breast Cancer
Started Jun 2026
87 enrolled
HER2-positive Metastatic Breast CancerHER2-positive 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.