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FDC of Pertuzumab and Trastuzumab SC
FDC of Pertuzumab and Trastuzumab 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, RO7198574, RG6264.
This fixed-dose combination of two monoclonal antibodies blocks HER2 signaling by targeting the HER2 receptor from different epitopes, preventing tumor cell growth and survival.
This fixed-dose combination of two monoclonal antibodies blocks HER2 signaling by targeting the HER2 receptor from different epitopes, 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 | FDC of Pertuzumab and Trastuzumab SC |
|---|---|
| Also known as | Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, RO7198574, RG6264 |
| 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 and trastuzumab are both HER2-targeted monoclonal antibodies that work synergistically to inhibit HER2-driven cancer cell proliferation. Trastuzumab binds to domain IV of HER2 and mediates antibody-dependent cellular cytotoxicity, while pertuzumab binds to domain II and blocks ligand-induced HER2 heterodimerization. The subcutaneous formulation improves patient convenience and tolerability compared to intravenous administration.
Approved indications
- HER2-positive metastatic breast cancer
- HER2-positive early breast cancer (neoadjuvant and adjuvant settings)
Common side effects
- Infusion-related reactions
- Cardiotoxicity / left ventricular dysfunction
- Diarrhea
- Nausea
- Fatigue
- Headache
- Injection site reactions
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:
- FDC of Pertuzumab and Trastuzumab SC CI brief — competitive landscape report
- FDC of Pertuzumab and Trastuzumab SC updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about FDC of Pertuzumab and Trastuzumab SC
What is FDC of Pertuzumab and Trastuzumab SC?
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Is FDC of Pertuzumab and Trastuzumab SC also known as anything else?
What drug class is FDC of Pertuzumab and Trastuzumab SC in?
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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, RO7198574, RG6264
- Compare: FDC of Pertuzumab and Trastuzumab SC vs similar drugs
- Pricing: FDC of Pertuzumab and Trastuzumab SC cost, discount & access