Last reviewed · How we verify
Trastuzumab IV
Trastuzumab IV is a Monoclonal antibody Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Adjuvant treatment of HER2-positive breast cancer, Treatment of HER2-positive metastatic breast cancer. Also known as: Herceptin, RO0452317, Herceptin®, Herceptin-150 mg.
Trastuzumab IV works by targeting and binding to the HER2/neu receptor on cancer cells, triggering an immune response and inhibiting cell growth.
Trastuzumab IV is an antibody that inhibits the receptor protein-tyrosine kinase erbB-2. It is used to treat various conditions, including HER2-positive early breast cancer, stage II breast cancer, and breast cancer, among others.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Trastuzumab IV |
|---|---|
| Also known as | Herceptin, RO0452317, Herceptin®, Herceptin-150 mg |
| Sponsor | Hoffmann-La Roche |
| Drug class | Monoclonal antibody |
| Target | HER2/neu receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This monoclonal antibody binds to the extracellular domain of the HER2/neu receptor, preventing it from interacting with its ligands and triggering downstream signaling pathways that promote cell growth and survival. By inhibiting these pathways, trastuzumab IV can help slow or stop the growth of HER2-positive cancer cells.
Approved indications
- Adjuvant treatment of HER2-positive breast cancer
- Treatment of HER2-positive metastatic breast cancer
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Headache
- Muscle pain
Key clinical trials
- Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial (PHASE1)
- Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer (PHASE1)
- Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer (PHASE1)
- Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene (PHASE1)
- Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management (PHASE2)
- Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation (PHASE1, PHASE2)
- Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma (PHASE2)
- Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Trastuzumab IV CI brief — competitive landscape report
- Trastuzumab IV updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about Trastuzumab IV
What is Trastuzumab IV?
How does Trastuzumab IV work?
What is Trastuzumab IV used for?
Who makes Trastuzumab IV?
Is Trastuzumab IV also known as anything else?
What drug class is Trastuzumab IV in?
What development phase is Trastuzumab IV in?
What are the side effects of Trastuzumab IV?
What does Trastuzumab IV target?
Related
- Drug class: All Monoclonal antibody drugs
- Target: All drugs targeting HER2/neu receptor
- Manufacturer: Hoffmann-La Roche — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Adjuvant treatment of HER2-positive breast cancer
- Indication: Drugs for Treatment of HER2-positive metastatic breast cancer
- Also known as: Herceptin, RO0452317, Herceptin®, Herceptin-150 mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing