Missing content? – Request curation!
Request curation for specific Genes, variants, or PubMed publications.
Have questions, comments or suggestions? - Let us know!
Email us at : ckbsupport@jax.org
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 |
Molecular Profile | Treatment Approach |
---|
Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
---|
Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
---|---|---|---|
Ramucirumab | Ramucirumab | 10 | 14 |
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 | 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 | 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 | 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... |
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 | 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 | 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... |