MedPath

panitumumab

Generic Name
panitumumab
Brand Names
Vectibix
Drug Type
Biotech
CAS Number
339177-26-3
Unique Ingredient Identifier
6A901E312A

Overview

Panitumumab (ABX-EGF) is a recombinant human IgG2 monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR). This drug is an antineoplastic agent. Panitumumab was granted FDA approval on 27 September 2006.

Indication

美国FDA批准:用于野生型KRAS(外显子2)转移性结直肠癌(mCRC)患者的一线治疗。

Associated Conditions

  • Metastatic Colorectal Cancer (CRC)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/31
Phase 3
Not yet recruiting
2025/02/11
Early Phase 1
Recruiting
2025/02/11
Phase 2
Recruiting
2024/12/03
Phase 2
Recruiting
National Cancer Institute, Naples
2024/07/19
Phase 3
Recruiting
National Cancer Institute, Naples
2024/07/08
Phase 3
Recruiting
IFOM ETS - The AIRC Institute of Molecular Oncology
2024/03/27
Phase 2
Recruiting
2024/03/18
Phase 2
Recruiting
Matteo's Friends
2024/02/20
Phase 2
Recruiting
Nicholas DeVito, MD
2024/02/12
Phase 3
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Amgen Inc
55513-954
INTRAVENOUS
100 mg in 5 mL
8/25/2021
Amgen Inc
55513-956
INTRAVENOUS
400 mg in 20 mL
8/25/2021

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
12/3/2007

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
Vectibix Concentrate for Solution for Infusion 100 mg/vial
SIN14498P
INFUSION, SOLUTION CONCENTRATE
100 mg/vial
1/27/2014

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
VECTIBIX panitumumab 400mg/20mL concentrated injection vial
128332
Medicine
A
5/14/2008
VECTIBIX panitumumab 100mg/5mL concentrated injection vial
128270
Medicine
A
5/14/2008

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