Drug profile · INN
trastuzumab
HERZUMA
trastuzumab (HERZUMA) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: intravenous. Current US regulatory status: approved.
Drug details — trastuzumab
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L01)
- Route
- INTRAVENOUS
- Patents
- 4
- Programs
- 71
- Data quality
- 0.84
Quick answer
trastuzumab (HERZUMA) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: intravenous. Current US regulatory status: approved.
Key facts
Mechanism of action
Receptor protein-tyrosine kinase erbB-2 inhibitor
Primary target: Receptor tyrosine-protein kinase erbB-2
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
| PMDA | approved | — |
| NMPA | clinical trials | — |
Recent coverage
5 Notable Oncology FDA Approvals Granted in May: A B2B Analysis
In May 2026, the FDA granted five major oncology approvals, including a first-in-class combination for non-muscle invasive bladder cancer. This analysis covers the approvals, their competitive impact, and next milestones for pharma teams.
Generic Oncology Drugs in Egypt: Market Analysis & Regional Impact
This article delves into the market dynamics of generic oncology drugs in Egypt, highlighting their role in cancer treatment and regional healthcare impact.
Biosimilar Market Growth India: Key Drivers, Challenges & Opportunities
The biosimilar market in India is poised for significant growth, driven by increasing demand for affordable biologics like Trastuzumab, alongside various challenges and opportunities.
PMDA Biosimilar Framework: Impact on Trastuzumab Biosimilars in Japan
This article delves into the PMDA biosimilar framework and its significant influence on the development and approval of trastuzumab biosimilars in Japan.
Pipeline programs
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Frequently asked questions
What is trastuzumab?
trastuzumab (HERZUMA) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: intravenous. Current US regulatory status: approved.
What is the brand name for trastuzumab?
HERZUMA is a marketed brand name for trastuzumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of trastuzumab?
trastuzumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.