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Ref Type
PMID
Authors
Title Cyramza (ramucirumab) FDA Drug Label
Journal
Vol
Issue
Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125477
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Ramucirumab Ramucirumab 10 13
Drug Name Trade Name Synonyms Drug Classes Drug Description
Ramucirumab Cyramza LY3009806 VEGFR2 Antibody 4 Cyramza (ramucirumab) is a monoclonal antibody, which binds and inhibits VEGFR2 (KDR) resulting in decreased angiogenesis (PMID: 24094768). Cyramza (ramucirumab) is FDA approved for use as a monotherapy or in combination with paclitaxel in patients with gastric or gastroesophageal junction adenocarcinoma who progressed on chemotherapy, in combination with erlotinib as first-line therapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations or L858R, in combination with decetaxel in patients with NSCLC who progressed on prior therapy, in combination with FOLFIRI in patients with colorectal cancer who progressed on prior therapy, and as monotherapy in patients with hepatocellular carcinoma who have received sorafenib (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown gastric adenocarcinoma not applicable Paclitaxel + Ramucirumab FDA approved Actionable In a Phase III trial (RAINBOW) that supported FDA approval, Cyramza (ramucirumab) and Taxol (paclitaxel) combination treatment significantly improved overall survival (9.6 vs 7.4 mo, HR=0.807, p=0.017) compared to Taxol (paclitaxel) alone in patients with advanced gastric or gastroesophageal junction adenocarcinoma who progressed on prior chemotherapy (PMID: 25240821; NCT01170663). 25240821 detail...
Unknown unknown lung non-small cell carcinoma not applicable Docetaxel + Ramucirumab FDA approved Actionable In a Phase III trial (REVEL) that supported FDA approval, Cyramza (ramucirumab) and Taxotere (docetaxel) combination treatment resulted in improved overall survival (10.5 vs 9.1 mo, HR=0.86, p=0.023) compared to Taxotere (docetaxel) and a placebo in patients with metastatic non-small cell lung cancer whose disease progressed on prior chemotherapy (PMID: 24933332; NCT01168973). 24933332 detail...
Unknown unknown gastroesophageal junction adenocarcinoma not applicable Paclitaxel + Ramucirumab FDA approved Actionable In a Phase III trial (RAINBOW) that supported FDA approval, Cyramza (ramucirumab) and Taxol (paclitaxel) combination treatment significantly improved overall survival (9.6 vs 7.4 mo, HR=0.807, p=0.017) compared to Taxol (paclitaxel) alone in patients with advanced gastric or gastroesophageal junction adenocarcinoma who progressed on prior chemotherapy (PMID: 25240821; NCT01170663). 25240821 detail...
Unknown unknown gastric adenocarcinoma not applicable Ramucirumab FDA approved Actionable In a Phase III trial (REGARD) that supported FDA approval, treatment with Cyramza (ramucirumab) improved median overall survival (5.2 vs 3.8 mo, HR=0.776, p=0.047) in aptients with compared to placebo in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma whose disease progressed after chemotherapy (PMID: 24094768; NCT00917384). 24094768 detail...
Unknown unknown hepatocellular carcinoma not applicable Ramucirumab FDA approved Actionable In a Phase III trial (REACH-2) that supported FDA approval, Cyramza (ramucirumab) treatment resulted in significantly improved overall survival (8.7 vs 7.3 months, HR=0.71, p=0.0199) and progression-free survival (2.8 vs 1.6 months, HR=0.452, p<0.0001) in hepatocellular carcinoma patients with baseline AFP of 400 ng/ml or higher, and progressed on or were intolerant to Nexavar (sorafenib) (PMID: 30665869; NCT02435433). 30665869 detail...
Unknown unknown colorectal cancer not applicable Fluorouracil + Irinotecan + Leucovorin + Ramucirumab FDA approved Actionable In a Phase III trial (RAISE) that supported FDA approval, treatment with a combination of Cyramza (ramucirumab) and the FOLFIRI chemotherapy regimen improved median overall survival (13.3 vs 11.7 mo, HR=0.844, p=0.0219) in patients with metastatic colorectal cancer (PMID: 25877855; NCT01183780). 25877855 detail...
Unknown unknown gastroesophageal junction adenocarcinoma not applicable Ramucirumab FDA approved Actionable In a Phase III trial (REGARD) that supported FDA approval, treatment with Cyramza (ramucirumab) improved median overall survival (5.2 vs 3.8 mo, HR=0.776, p=0.047) in aptients with compared to placebo in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma whose disease progressed after chemotherapy (PMID: 24094768; NCT00917384). 24094768 detail...