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Adjuvant trastuzumab (adjuvant-trastuzumab)
Adjuvant trastuzumab (generic name: adjuvant-trastuzumab) is a Monoclonal antibody drug developed by Pfizer Inc.. It is currently in Phase 2 development.
Trastuzumab 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 HER2-positive Carcinoma of Breast, Inflammatory Breast Cancer, and HER2 Positive Early Breast Cancer.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | adjuvant-trastuzumab |
|---|---|
| Sponsor | Pfizer Inc. |
| Modality | Monoclonal antibody |
| Phase | Phase 2 |
Approved indications
Common side effects
- DIARRHOEA
- NAUSEA
- FATIGUE
- Diarrhoea
- Nausea
- Fatigue
- ALOPECIA
- ARTHRALGIA
- Alopecia
- RASH
- VOMITING
- HEADACHE
Key clinical trials
- HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer (EARLY_PHASE1)
- CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (PHASE2)
- Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery (PHASE2)
- Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects (PHASE3)
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)
- Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) (PHASE2)
- Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab (PHASE2)
- A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (PHASE2)
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:
- Adjuvant trastuzumab CI brief — competitive landscape report
- Adjuvant trastuzumab updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Adjuvant trastuzumab
What is Adjuvant trastuzumab?
Who makes Adjuvant trastuzumab?
What is the generic name of Adjuvant trastuzumab?
What development phase is Adjuvant trastuzumab in?
What are the side effects of Adjuvant trastuzumab?
Related
- Manufacturer: Pfizer Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing