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]. First approved in 2019.
Drug data last refreshed 21h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONTRUZANT is a monoclonal antibody that targets HER2/Neu receptors, used to treat HER2-positive breast cancer and gastric cancers. It works by binding to HER2 on cancer cell surfaces, blocking growth signals and triggering immune-mediated cell death. This is a biosimilar to the reference trastuzumab (Herceptin).
$0.002BPart D
PeakONTRUZANT is in peak commercial phase with growing adoption in the competitive trastuzumab biosimilar market, supporting mid-size commercial and manufacturing 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 Trastuzumab Deruxtecan (T-DXd) and Cetuximab in People With Colorectal Cancer
Started Oct 2026
27 enrolled
Colorectal CancerAdenocarcinoma of the ColonAdenocarcinoma of the Rectum
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 Sep 2026
220 enrolled
Hormone Receptor PositiveHER2-low or HER2-ultralowUnresectable or Metastatic Breast Cancer
BL-M07D1 (Trastuzumab Brengitecan T-bren) vs Standard of Care Platinum-based Chemotherapy (PBC) for HER2-expressing Metastatic Urothelial Cancer After Progression on Anti-PD-(L)1-based Therapy
Started Sep 2026
520 enrolled
Urothelial CancerMetastatic Urothelial CancerBladder Cancer+9 more
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
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
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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.