BLAINTRAVENOUSVIALPriority Review
Approved
Sep 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HERCEPTIN (trastuzumab) is a monoclonal antibody that targets HER2/neu receptors, approved in 1998 for HER2-positive breast cancer and other HER2-expressing malignancies. It works by binding to HER2 receptors on cancer cells, blocking growth signaling and triggering immune-mediated tumor destruction. This pioneering targeted therapy transformed treatment of HER2-positive cancers and established the foundation for precision oncology.
$0.004BPart D
LOE ApproachingApproaching loss of exclusivity with moderate Part D activity signals a mature product requiring defensive strategies and transition planning for teams.
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 Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer
Started May 2026
60 enrolled
HER2-positive Recurrent or Metastatic 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 Apr 2026
650 enrolled
HER2-positive Breast Cancer
A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer
Started Apr 2026
596 enrolled
HER2-positive Breast Cancer
A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers
Started Feb 2026
150 enrolled
Healthy Male Participants
A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer
Started Feb 2026
14 enrolled
Non-Small Cell Lung CancerNon-small Cell Lung Cancer Stage IINon-Small Cell Lung Cancer Stage IIIA+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.