Last reviewed · How we verify
Pertuzumab and Trastuzumab FDC SC
Pertuzumab and Trastuzumab FDC SC is a HER2-targeted monoclonal antibody combination Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for HER2-positive metastatic breast cancer, HER2-positive early breast cancer (neoadjuvant and adjuvant settings). Also known as: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, PHESGO™, PH FDC SC, RG6264.
This fixed-dose combination of two monoclonal antibodies blocks HER2 signaling by targeting different epitopes on the HER2 receptor, preventing tumor cell growth and survival.
This fixed-dose combination of two monoclonal antibodies blocks HER2 signaling by targeting different epitopes on the HER2 receptor, preventing tumor cell growth and survival. Used for HER2-positive metastatic breast cancer, HER2-positive early breast cancer (neoadjuvant and adjuvant settings).
At a glance
| Generic name | Pertuzumab and Trastuzumab FDC SC |
|---|---|
| Also known as | Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, PHESGO™, PH FDC SC, RG6264, RO7198574 |
| Sponsor | Hoffmann-La Roche |
| Drug class | HER2-targeted monoclonal antibody combination |
| Target | HER2 (human epidermal growth factor receptor 2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pertuzumab binds to HER2 domain II and blocks ligand-induced HER2 heterodimerization, while trastuzumab binds to domain IV and mediates antibody-dependent cellular cytotoxicity (ADCC) and inhibits HER2 signaling. Together, they provide complementary mechanisms of HER2 inhibition in HER2-positive cancers. The subcutaneous formulation improves patient convenience compared to intravenous administration.
Approved indications
- HER2-positive metastatic breast cancer
- HER2-positive early breast cancer (neoadjuvant and adjuvant settings)
Common side effects
- Diarrhea
- Nausea
- Fatigue
- Vomiting
- Decreased left ventricular ejection fraction (LVEF)
- Infusion-related reactions
- Rash
Key clinical trials
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (PHASE1, PHASE2)
- A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer (PHASE3)
- 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 to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) (PHASE3)
- A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Inavolisib Plus Pertuzumab and Trastuzumab as Subcutaneous (PH-FDC SC) and 3-week Cycle Nab-paclitaxel for PIK3CA-mutated, HER2+, eBC (PHASE2)
- Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer (PHASE2)
- A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer (PHASE2)
- PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer (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 and Trastuzumab FDC SC CI brief — competitive landscape report
- Pertuzumab and Trastuzumab FDC SC updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about Pertuzumab and Trastuzumab FDC SC
What is Pertuzumab and Trastuzumab FDC SC?
How does Pertuzumab and Trastuzumab FDC SC work?
What is Pertuzumab and Trastuzumab FDC SC used for?
Who makes Pertuzumab and Trastuzumab FDC SC?
Is Pertuzumab and Trastuzumab FDC SC also known as anything else?
What drug class is Pertuzumab and Trastuzumab FDC SC in?
What development phase is Pertuzumab and Trastuzumab FDC SC in?
What are the side effects of Pertuzumab and Trastuzumab FDC SC?
What does Pertuzumab and Trastuzumab FDC SC target?
Related
- Drug class: All HER2-targeted monoclonal antibody combination 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
- Indication: Drugs for HER2-positive early breast cancer (neoadjuvant and adjuvant settings)
- Also known as: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, PHESGO™, PH FDC SC, RG6264, RO7198574
- Compare: Pertuzumab and Trastuzumab FDC SC vs similar drugs
- Pricing: Pertuzumab and Trastuzumab FDC SC cost, discount & access