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Pertuzumab (Perjeta®)
Pertuzumab (Perjeta®) is a HER2 inhibitor monoclonal antibody Biologic drug developed by Zydus Lifesciences Limited. It is currently in Phase 3 development for HER2-positive metastatic breast cancer (in combination with trastuzumab and chemotherapy), HER2-positive early breast cancer (neoadjuvant and adjuvant settings).
Pertuzumab is a monoclonal antibody that binds to HER2 and blocks its dimerization with other HER receptors, preventing cancer cell growth signaling.
Pertuzumab is a monoclonal antibody that binds to HER2 and blocks its dimerization with other HER receptors, preventing cancer cell growth signaling. Used for HER2-positive metastatic breast cancer (in combination with trastuzumab and chemotherapy), HER2-positive early breast cancer (neoadjuvant and adjuvant settings).
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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 | Pertuzumab (Perjeta®) |
|---|---|
| Sponsor | Zydus Lifesciences Limited |
| Drug class | HER2 inhibitor monoclonal antibody |
| Target | HER2 (Human Epidermal Growth Factor Receptor 2) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pertuzumab targets the extracellular domain II of HER2, a different epitope than trastuzumab, and prevents HER2 from pairing with HER3 and other HER family members. This dual blockade of HER2 signaling pathways enhances anti-tumor activity compared to HER2 inhibition alone. It is used in combination with trastuzumab and chemotherapy to treat HER2-positive breast cancers.
Approved indications
- HER2-positive metastatic breast cancer (in combination with trastuzumab and chemotherapy)
- HER2-positive early breast cancer (neoadjuvant and adjuvant settings)
Common side effects
- Diarrhea
- Nausea
- Fatigue
- Vomiting
- Rash
- Left ventricular dysfunction
Key clinical trials
- A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo®. (PHASE1)
- TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (PHASE2)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (PHASE1, PHASE2)
- 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)
- A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer (PHASE2)
- Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) (PHASE1, PHASE2)
- A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer (PHASE3)
- A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer (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:
- Pertuzumab (Perjeta®) CI brief — competitive landscape report
- Pertuzumab (Perjeta®) updates RSS · CI watch RSS
- Zydus Lifesciences Limited portfolio CI
Frequently asked questions about Pertuzumab (Perjeta®)
What is Pertuzumab (Perjeta®)?
How does Pertuzumab (Perjeta®) work?
What is Pertuzumab (Perjeta®) used for?
Who makes Pertuzumab (Perjeta®)?
What drug class is Pertuzumab (Perjeta®) in?
What development phase is Pertuzumab (Perjeta®) in?
What are the side effects of Pertuzumab (Perjeta®)?
What does Pertuzumab (Perjeta®) target?
Related
- Drug class: All HER2 inhibitor monoclonal antibody drugs
- Target: All drugs targeting HER2 (Human Epidermal Growth Factor Receptor 2)
- Manufacturer: Zydus Lifesciences Limited — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for HER2-positive metastatic breast cancer (in combination with trastuzumab and chemotherapy)
- Indication: Drugs for HER2-positive early breast cancer (neoadjuvant and adjuvant settings)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing