MedPath

Amivantamab

Generic Name
Amivantamab
Brand Names
Rybrevant
Drug Type
Biotech
CAS Number
2171511-58-1
Unique Ingredient Identifier
0JSR7Z0NB6

Overview

Amivantamab, also known as JNJ-61186372, is an anti-EGFR-MET bispecific antibody, derived from Chinese hamster ovary cells, approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Patients with NSCLC often develop resistance to drugs that target EGFR and MET individually, so amivantamab was developed to attack both targets, reducing the chance of resistance developing. Amivantamab was found to be more effective than the EGFR inhibitor erlotinib or the MET inhibitor crizotinib in vivo. Patients with NSCLC with exon 20 insertion mutations in EGFR do not respond to tyrosine kinase inhibitors, and were generally treated with platinum-based therapy. Amivantamab was granted FDA approval on 21 May 2021, followed by the approval by the EMA on 9 December 2021 and Health Canada on 30 March 2022.

Indication

Amivantamab is indicated in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

Associated Conditions

  • Locally Advanced Non-Small Cell Lung Cancer
  • Metastatic Non-Small Cell Lung Cancer

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/14
Not Applicable
Not yet recruiting
2025/01/20
Phase 2
Recruiting
University Hospital, Essen
2024/12/27
Phase 3
Recruiting
2024/10/31
Phase 2
Recruiting
2024/10/29
Phase 3
Recruiting
2024/10/09
Phase 1
Recruiting
Institute of Cancer Research, United Kingdom
2024/08/01
Phase 1
Active, not recruiting
2024/04/25
Phase 1
Recruiting
2023/11/03
Phase 2
Recruiting
2023/10/16
Phase 1
Active, not recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
12/9/2021

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
RYBREVANT CONCENTRATE FOR SOLUTION FOR INFUSION 350MG/7ML
SIN16548P
INFUSION, SOLUTION CONCENTRATE
350mg/7ml
7/13/2022

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
RYBREVANT amivantamab 350 mg/7 mL concentrate for solution for infusion vial
376832
Medicine
A
12/1/2022

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.