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Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf is a Endoglycosidase [EPC] Small molecule drug developed by Genentech, Inc.. It is currently FDA-approved. Also known as: PHESGO™, PH FDC SC, Fixed dose combination of trastuzumab and pertuzumab administered subcutaneously, RG6264.
At a glance
| Generic name | Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf |
|---|---|
| Also known as | PHESGO™, PH FDC SC, Fixed dose combination of trastuzumab and pertuzumab administered subcutaneously, RG6264, RO7198574 |
| Sponsor | Genentech, Inc. |
| Drug class | Endoglycosidase [EPC] |
| Modality | Small molecule |
| 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 cardiomyopathy. ( 2.3 , 5.1 ) Embryo-fetal Toxicity: Exposure to PHESGO can result in embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception. ( 5.2 , 8.1 , 8.3 ) Pulmonary Toxicity: Discontinue PHESGO for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. ( 5.3 ) Cardiomyopathy PHESGO administration can result in subclinical and clinical cardiac failure. The incidence and severity were highest in patients receiving PHESGO with anthracycline-containing chemotherapy regimens. Evaluate cardiac function prior to and during treatment with PHESGO. Discontinue PHESGO treatment in patients receiving adjuvant therapy and withhold PHESGO in patients with metastatic disease for clinically significant decrease in left ventricular function [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] . Embryo-fetal Toxicity Exposure to PHESGO can result in embryo-fetal death and birth defects, including oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1) , (8.3) ]. Pulmonary Toxicity PHESGO administration can result in serious and fatal pulmonary toxicity. Discontinue PHESGO for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Monitor patients until symptoms completely resolve [see Warnings and Precautions (5.3) ].
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
- Ejection fraction decreased
- Cardiac failure
- Pneumonitis/pulmonary fibrosis
- Neutropenic sepsis
- Neutrophil count decreased
- Acute myocardial infarction
Key clinical trials
- Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma (PHASE3)
- 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)
- Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer (PHASE2)
- 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)
- Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer (NA)
- The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ 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, Trastuzumab, and Hyaluronidase-zzxf CI brief — competitive landscape report
- Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf updates RSS · CI watch RSS
- Genentech, Inc. portfolio CI
Frequently asked questions about Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
What is Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf?
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf is a Endoglycosidase [EPC] drug developed by Genentech, Inc..
Who makes Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf?
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf is developed and marketed by Genentech, Inc. (see full Genentech, Inc. pipeline at /company/genentech-inc).
Is Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf also known as anything else?
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf is also known as PHESGO™, PH FDC SC, Fixed dose combination of trastuzumab and pertuzumab administered subcutaneously, RG6264, RO7198574.
What drug class is Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf in?
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf belongs to the Endoglycosidase [EPC] class. See all Endoglycosidase [EPC] drugs at /class/endoglycosidase-epc.
What development phase is Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf in?
Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf is FDA-approved (marketed).
What are the side effects of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf?
Common side effects of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf include Radiation skin injury, Arthralgia, Diarrhea, Injection site reaction, Dyspepsia, Asthenia. Serious adverse events: Febrile neutropenia, Ejection fraction decreased, Cardiac failure, Pneumonitis/pulmonary fibrosis.
Related
- Drug class: All Endoglycosidase [EPC] drugs
- Manufacturer: Genentech, Inc. — full pipeline
- Also known as: PHESGO™, PH FDC SC, Fixed dose combination of trastuzumab and pertuzumab administered subcutaneously, RG6264, RO7198574
- Compare: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf vs similar drugs
- Pricing: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf cost, discount & access