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 | ||
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
RYBREVANT | 02526182 | Solution - Intravenous | 350 MG / 7 ML | 4/26/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
RYBREVANT 1600 MG SOLUCION INYECTABLE | 1211594002 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
RYBREVANT 350 MG CONCENTRADO PARA SOLUCION PARA PERFUSION | 1211594001 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
RYBREVANT 2240 MG SOLUCION INYECTABLE | 1211594003 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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