Overview
Ramucirumab is a human monoclonal antibody (IgG1) against vascular endothelial growth factor receptor 2 (VEGFR2), a type II trans-membrane tyrosine kinase receptor expressed on endothelial cells. By binding to VEGFR2, ramucirumab prevents binding of its ligands (VEGF-A, VEGF-C, and VEGF-D), thereby preventing VEGF-stimulated receptor phosphorylation and downstream ligand-induced proliferation, permeability, and migration of human endothelial cells. VEGFR stimulation also mediates downstream signalling required for angiogenesis and is postulated to be heavily involved in cancer progression, making it a highly likely drug target. In contrast to other agents directed against VEGFR-2, ramucirumab binds a specific epitope on the extracellular domain of VEGFR-2, thereby blocking all VEGF ligands from binding to it. Ramucirumab is indicated for us in advanced gastric or gastro-esophageal junction adenocarcinoma as a single agent or in combination with paclitaxel after prior fluoropyrimidine- or platinum-containing chemotherapy.
Background
Ramucirumab is a human monoclonal antibody (IgG1) against vascular endothelial growth factor receptor 2 (VEGFR2), a type II trans-membrane tyrosine kinase receptor expressed on endothelial cells. By binding to VEGFR2, ramucirumab prevents binding of its ligands (VEGF-A, VEGF-C, and VEGF-D), thereby preventing VEGF-stimulated receptor phosphorylation and downstream ligand-induced proliferation, permeability, and migration of human endothelial cells. VEGFR stimulation also mediates downstream signalling required for angiogenesis and is postulated to be heavily involved in cancer progression, making it a highly likely drug target. In contrast to other agents directed against VEGFR-2, ramucirumab binds a specific epitope on the extracellular domain of VEGFR-2, thereby blocking all VEGF ligands from binding to it. Ramucirumab is indicated for us in advanced gastric or gastro-esophageal junction adenocarcinoma as a single agent or in combination with paclitaxel after prior fluoropyrimidine- or platinum-containing chemotherapy.
Indication
Ramucirumab is indicated for the treatment of advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma as a single agent or in combination with paclitaxel for patients who progress after prior fluoropyrimidine- or platinum-containing chemotherapy. It is indicated, in combination with erlotinib, for the first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor exon 19 deletions or exon 21 (L858R) point mutations. It is also indicated in combination with docetaxel for the treatment of metastatic non-small cell lung cancer in patients who have progressed following prior platinum-based chemotherapy. Patients who have EGFR or ALK genomic aberrations should also have disease progression following FDA-approved therapy for these aberrations. Ramucirumab, in combination with FOLFIRI (folinic acid, fluorouracil, and irinotecan), is indicated for the treatment of metastatic colorectal cancer in patients who have progressed following therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Lastly, ramucirumab is indicated for the treatment of hepatocellular carcinoma in patients with an alpha-fetoprotein level ≥400 ng/mL and have previously been treated with sorafenib.
Associated Conditions
- Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- Hepatocellular Carcinoma
- Metastatic Colorectal Cancer (CRC)
- Metastatic Non-Small Cell Lung Cancer
- Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/30 | Phase 1 | Recruiting | |||
2025/01/13 | Phase 1 | Recruiting | FBD Biologics Limited | ||
2024/11/08 | Phase 2 | Recruiting | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | ||
2024/11/05 | Phase 1 | Not yet recruiting | City of Hope Medical Center | ||
2024/09/27 | Phase 2 | Recruiting | |||
2024/08/21 | Phase 2 | Not yet recruiting | |||
2024/08/07 | Phase 1 | Active, not recruiting | |||
2024/06/06 | Phase 1 | Recruiting | |||
2024/02/09 | Phase 2 | Recruiting | |||
2024/01/12 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eli Lilly and Company | 0002-7669 | INTRAVENOUS | 10 mg in 1 mL | 5/29/2019 | |
| Eli Lilly and Company | 0002-7678 | INTRAVENOUS | 10 mg in 1 mL | 5/29/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/19/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CYRAMZA CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML | SIN15035P | INJECTION, SOLUTION, CONCENTRATE | 10mg/ml | 6/21/2016 | |
| CYRAMZA CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/50ML | SIN15036P | INJECTION, SOLUTION, CONCENTRATE | 10mg/ml | 6/21/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ramucirumab Injection | 国药准字SJ20220012 | 生物制品 | 注射剂 | 3/16/2022 | |
| Ramucirumab Injection | 国药准字SJ20220011 | 生物制品 | 注射剂 | 3/16/2022 |
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 |
|---|---|---|---|---|---|
| CYRAMZA ramucirumab 500 mg/50 mL solution for intravenous infusion vial | 227352 | Medicine | A | 7/23/2015 | |
| CYRAMZA ramucirumab 100 mg/10 mL solution for intravenous infusion vial | 227351 | Medicine | A | 7/23/2015 |