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EU-Perjeta®
EU-Perjeta is a monoclonal antibody that binds to HER2 and blocks its dimerization with other HER family receptors, inhibiting tumor cell growth signaling.
EU-Perjeta is a monoclonal antibody that binds to HER2 and blocks its dimerization with other HER family receptors, inhibiting tumor cell growth signaling. Used for HER2-positive metastatic breast cancer, HER2-positive early breast cancer (neoadjuvant and adjuvant settings).
At a glance
| Generic name | EU-Perjeta® |
|---|---|
| Sponsor | Shanghai Henlius Biotech |
| Drug class | HER2 inhibitor monoclonal antibody |
| Target | HER2 (Human Epidermal Growth Factor Receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
EU-Perjeta (pertuzumab) is a HER2-directed monoclonal antibody that prevents HER2 from binding to its ligands and forming active dimers with other HER receptors, thereby disrupting downstream signaling pathways that drive cancer cell proliferation. It is often used in combination with trastuzumab (Herceptin) and chemotherapy to enhance anti-tumor activity in HER2-positive breast cancers.
Approved indications
- HER2-positive metastatic breast cancer
- HER2-positive early breast cancer (neoadjuvant and adjuvant settings)
Common side effects
- Diarrhea
- Nausea
- Fatigue
- Rash
- Vomiting
- Left ventricular dysfunction
Key clinical trials
- A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo®. (PHASE1)
- Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer (PHASE3)
- Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer. (PHASE3)
- A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer (PHASE3)
- A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers (PHASE1)
- Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects (PHASE1)
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 |