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Trastuzumab Injection
Trastuzumab Injection is a HER2-targeted monoclonal antibody Small molecule drug developed by Spanish Breast Cancer Research Group. It is currently in Phase 3 development for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant and neoadjuvant settings), HER2-positive gastric cancer. Also known as: Herceptin.
Trastuzumab is a monoclonal antibody that binds to HER2 receptors on cancer cells, blocking growth signals and triggering immune-mediated cell death.
Trastuzumab Injection is an antibody that inhibits the receptor tyrosine-protein kinase erbB-2, a receptor protein-tyrosine kinase. It is used to treat conditions such as Advanced HER2-positive Breast Cancer and HER2-positive Breast Cancer.
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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.
| 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 Injection |
|---|---|
| Also known as | Herceptin |
| Sponsor | Spanish Breast Cancer Research Group |
| Drug class | HER2-targeted monoclonal antibody |
| Target | HER2 (human epidermal growth factor receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Trastuzumab targets human epidermal growth factor receptor 2 (HER2), a protein overexpressed in certain breast cancers. By binding to HER2, it prevents ligand-induced signaling and recruits immune cells to destroy HER2-positive tumor cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Approved indications
- HER2-positive metastatic breast cancer
- HER2-positive early-stage breast cancer (adjuvant and neoadjuvant settings)
- HER2-positive gastric cancer
Common side effects
- Cardiotoxicity / left ventricular dysfunction
- Infusion reactions
- Nausea
- Diarrhea
- Fatigue
- Headache
- Anemia
Key clinical trials
- A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo®. (PHASE1)
- A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer (PHASE3)
- A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer (PHASE2)
- Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors (PHASE1)
- CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (PHASE2)
- A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer (PHASE2, PHASE3)
- Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects (PHASE3)
- TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention (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 Injection CI brief — competitive landscape report
- Trastuzumab Injection updates RSS · CI watch RSS
- Spanish Breast Cancer Research Group portfolio CI
Frequently asked questions about Trastuzumab Injection
What is Trastuzumab Injection?
How does Trastuzumab Injection work?
What is Trastuzumab Injection used for?
Who makes Trastuzumab Injection?
Is Trastuzumab Injection also known as anything else?
What drug class is Trastuzumab Injection in?
What development phase is Trastuzumab Injection in?
What are the side effects of Trastuzumab Injection?
What does Trastuzumab Injection target?
Related
- Drug class: All HER2-targeted monoclonal antibody drugs
- Target: All drugs targeting HER2 (human epidermal growth factor receptor 2)
- Manufacturer: Spanish Breast Cancer Research Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for HER2-positive metastatic breast cancer
- Indication: Drugs for HER2-positive early-stage breast cancer (adjuvant and neoadjuvant settings)
- Indication: Drugs for HER2-positive gastric cancer
- Also known as: Herceptin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing