BLAIV (INFUSION)POWDER
Approved
Jan 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
ONTRUZANT (trastuzumab) by Samsung Bioepis is her2/neu/cerbb2 antagonists [moa]. Approved for breast cancer, gastric cancer. First approved in 2019.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONTRUZANT (trastuzumab) is a monoclonal antibody that targets the HER2/neu receptor, blocking growth signals in HER2-positive cancers. It is approved across 12 solid tumor indications including breast, gastric, lung, ovarian, cervical, head and neck, esophageal, colorectal, small cell lung, melanoma, endometrial cancers, and other solid tumors. By antagonizing HER2/neu signaling, it inhibits tumor cell proliferation and induces antibody-dependent cellular cytotoxicity.
$2.0MPart D
PeakONTRUZANT is at peak lifecycle with modest Part D spending, indicating a stable market position requiring focused commercial execution to defend biosimilar threats.
Mechanism of Action
HER2/Neu/cerbB2 Antagonists
Pharmacologic Class:
HER2/neu Receptor Antagonist
Indications (2)
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 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
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 Feb 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.