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Pertuzumab IV
Pertuzumab IV is a HER2 inhibitor monoclonal antibody Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for HER2-positive metastatic breast cancer (in combination with trastuzumab and chemotherapy), HER2-positive early-stage breast cancer (adjuvant and neoadjuvant settings), HER2-positive gastric cancer. Also known as: Perjeta, RO4368451, Perjeta®.
Pertuzumab is a monoclonal antibody that blocks HER2 dimerization, preventing HER2 from pairing with other HER receptors and inhibiting tumor cell growth signaling.
Pertuzumab is a monoclonal antibody that blocks HER2 dimerization, preventing HER2 from pairing with other HER receptors and inhibiting tumor cell growth signaling. Used for HER2-positive metastatic breast cancer (in combination with trastuzumab and chemotherapy), HER2-positive early-stage breast cancer (adjuvant and neoadjuvant settings), HER2-positive gastric 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. -
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 | Pertuzumab IV |
|---|---|
| Also known as | Perjeta, RO4368451, Perjeta® |
| Sponsor | Hoffmann-La Roche |
| 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
Pertuzumab binds to the extracellular dimerization interface of HER2, a receptor tyrosine kinase overexpressed in certain cancers. By preventing HER2 from forming heterodimers with HER3 and other HER family members, it blocks downstream signaling pathways critical for cancer cell proliferation and survival. This mechanism is complementary to trastuzumab, which binds a different epitope on HER2.
Approved indications
- HER2-positive metastatic breast cancer (in combination with trastuzumab and chemotherapy)
- HER2-positive early-stage breast cancer (adjuvant and neoadjuvant settings)
- HER2-positive gastric cancer
Common side effects
- Diarrhea
- Nausea
- Fatigue
- Vomiting
- Rash
- Left ventricular dysfunction
- Febrile neutropenia
Key clinical trials
- Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management (PHASE2)
- Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma (PHASE3)
- Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (PHASE2)
- A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer (PHASE3)
- Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients (PHASE1)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (PHASE1, 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:
- Pertuzumab IV CI brief — competitive landscape report
- Pertuzumab IV updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about Pertuzumab IV
What is Pertuzumab IV?
How does Pertuzumab IV work?
What is Pertuzumab IV used for?
Who makes Pertuzumab IV?
Is Pertuzumab IV also known as anything else?
What drug class is Pertuzumab IV in?
What development phase is Pertuzumab IV in?
What are the side effects of Pertuzumab IV?
What does Pertuzumab IV target?
Related
- Drug class: All HER2 inhibitor monoclonal antibody drugs
- Target: All drugs targeting HER2 (human epidermal growth factor receptor 2)
- Manufacturer: Hoffmann-La Roche — 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-stage breast cancer (adjuvant and neoadjuvant settings)
- Indication: Drugs for HER2-positive gastric cancer
- Also known as: Perjeta, RO4368451, Perjeta®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing