Overview
Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). It consists of two heavy chains and two lights chains that have 448 and 214 residues respectively. It was first approved by the FDA in 2012 for use with docetaxel and another HER2-targeted monoclonal antibody, trastuzumab, in the treatment of metastatic HER2-positive breast cancer. Its indicated conditions have since expanded to include use as both a neoadjuvant therapy and an adjuvant therapy in the treatment of HER2-positive breast cancers at high risk of recurrence.
Background
Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). It consists of two heavy chains and two lights chains that have 448 and 214 residues respectively. It was first approved by the FDA in 2012 for use with docetaxel and another HER2-targeted monoclonal antibody, trastuzumab, in the treatment of metastatic HER2-positive breast cancer. Its indicated conditions have since expanded to include use as both a neoadjuvant therapy and an adjuvant therapy in the treatment of HER2-positive breast cancers at high risk of recurrence.
Indication
Pertuzumab is indicated for intravenous administration in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. It is also indicated in combination with trastuzumab and other chemotherapies for the neoadjuvant treatment of HER2-positive locally advanced, inflammatory, or early-stage breast cancer as part of a complete treatment regimen and as adjuvant treatment in patients with HER2-positive early-stage breast cancer at high risk of recurrence. Pertuzumab is also indicated for subcutaneous injection - in combination with trastuzumab and hyaluronidase - in the treatment of HER2-positive breast cancers in adults.
Associated Conditions
- Inflammatory Breast Cancer (IBC)
- Locally Advanced Breast Cancer (LABC)
- Metastatic Breast Cancer
- Stage I Breast Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/02 | Not Applicable | Not yet recruiting | |||
2025/04/15 | Phase 2 | Recruiting | |||
2025/03/25 | Phase 3 | Not yet recruiting | |||
2025/03/24 | Phase 2 | Recruiting | |||
2025/03/14 | Phase 3 | Not yet recruiting | |||
2025/01/13 | Phase 1 | Recruiting | FBD Biologics Limited | ||
2024/12/24 | Phase 3 | Recruiting | Shanghai JMT-Bio Inc. | ||
2024/11/13 | Phase 1 | Recruiting | |||
2024/07/19 | Phase 2 | Not yet recruiting | |||
2024/07/08 | Phase 3 | Recruiting | IFOM ETS - The AIRC Institute of Molecular Oncology |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Genentech, Inc. | 50242-245 | SUBCUTANEOUS | 1200 mg in 15 mL | 11/16/2022 | |
Genentech, Inc. | 50242-145 | INTRAVENOUS | 30 mg in 1 mL | 10/20/2020 | |
Genentech, Inc. | 50242-260 | SUBCUTANEOUS | 600 mg in 10 mL | 11/16/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 3/4/2013 | ||
Authorised | 3/4/2013 | ||
Authorised | 12/21/2020 | ||
Authorised | 12/21/2020 | ||
Authorised | 3/4/2013 | ||
Authorised | 3/4/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
PHESGO SOLUTION FOR SUBCUTANEOUS INJECTION 600 MG/600 MG / 10 ML | SIN16248P | INJECTION, SOLUTION | 600 mg | 6/22/2021 | |
PERJETA CONCENTRATE FOR SOLUTION FOR INFUSION 420MG/14ML | SIN14501P | INFUSION, SOLUTION CONCENTRATE | 30 mg/ml | 2/5/2014 | |
PHESGO SOLUTION FOR SUBCUTANEOUS INJECTION 1200 MG/600 MG / 15 ML | SIN16247P | INJECTION, SOLUTION | 1200 mg | 6/22/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Pertuzumab Injection | 国药准字S20240054 | 生物制品 | 注射剂 | 12/17/2024 | |
Pertuzumab Injection | 国药准字S20240053 | 生物制品 | 注射剂 | 12/17/2024 | |
Pertuzumab Injection | 国药准字SJ20180029 | 生物制品 | 注射剂 | 9/22/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
PHESGO SOLUTION FOR SUBCUTANEOUS INJECTION 600MG/600MG IN 10ML | N/A | N/A | N/A | 6/25/2021 | |
PHESGO SOLUTION FOR SUBCUTANEOUS INJECTION 1200MG/600MG IN 15ML | N/A | N/A | N/A | 6/25/2021 | |
PERJETA CONCENTRATE FOR SOLUTION FOR INFUSION 420MG | N/A | N/A | N/A | 4/8/2014 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
PHESGO SC pertuzumab (rch) 1200mg and trastuzumab (rch) 600mg in 15mL solution for injection, vials | 332180 | Medicine | A | 7/6/2021 | |
PHESGO SC pertuzumab (rch) 600 mg and trastuzumab (rch) 600mg in 10mL solution for injection, vials | 332181 | Medicine | A | 7/6/2021 | |
PERJETA pertuzumab (rch) 30mg/mL concentrate injection vial | 196218 | Medicine | A | 5/6/2013 |