Last reviewed · How we verify
Phesgo
At a glance
| Generic name | Phesgo |
|---|---|
| Also known as | Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, Pertuzumab, Trastuzumab, and rHuPH20, Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC), RO7198574, RG6264 |
| Sponsor | Hoffmann-La Roche |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: PHESGO administration can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue PHESGO for cardiomyopath
Common side effects
- Radiation skin injury
- Arthralgia
- Diarrhea
- Injection site reaction
- Dyspepsia
- Asthenia
- Hot flush
- Pruritus
- Neutropenia
- Neutrophil count decreased
- Ejection fraction decreased
- Nausea
Serious adverse events
- Febrile neutropenia
- Cardiac failure
- Pneumonitis/pulmonary fibrosis
- Neutrophil count decreased
- Neutropenic sepsis
- Acute myocardial infarction
Key clinical trials
- A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo®. (PHASE1)
- Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma (PHASE3)
- A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer (PHASE3)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (PHASE1, PHASE2)
- A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (PHASE3)
- A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors (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)
- Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2+ Early Breast Cancer Undergoing HER2 Double-Blockade (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:
- Phesgo CI brief — competitive landscape report
- Phesgo updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI