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Pertuzumab

Generic Name
Pertuzumab
Brand Names
Perjeta, Perjeta-Herceptin, Phesgo
Drug Type
Biotech
CAS Number
380610-27-5
Unique Ingredient Identifier
K16AIQ8CTM

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

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
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