Difference between revisions of "Ramucirumab (Cyramza)"

Revision as of 19:39, 30 April 2021

General information

Class/mechanism: Recombinant human IgG1 monoclonal antibody, VEGFR2 (vascular endothelial growth factor receptor 2) antagonist. Ramucirumab binds VEGFR2 and blocks VEGFR ligands, VEGF-A, VEGF-C, and VEGF-D, which inhibits angiogenesis.^[1]^[2]^[3]
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.^[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Colorectal cancer

4/24/2015: Approved in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. (New disease entity; based on RAISE)

Gastric cancer

4/21/2014: Initial approval for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum- containing chemotherapy. (Based on REGARD)
11/5/2014: Approval and indication expanded for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. (Requirement for prior lines of treatment removed; based on RAINBOW)

Hepatocellular carcinoma

5/10/2019: Approved as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of at least 400 ng/mL and have been previously treated with sorafenib. (New disease entity; based on REACH-2)

Non-small cell lung cancer

12/12/2014: Approved for use in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. (New disease entity; based on REVEL)
5/29/2020: Approved in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. (Approval expanded to first-line setting in EGFR+ NSCLC; based on RELAY)

Also known as

Code names: IMC-1121B, LY3009806
Brand name: Cyramza

References

[insert-1] 1.0 ^1.1 ^1.2 Ramucirumab (Cyramza) package insert

[2] Ramucirumab (Cyramza) package insert (locally hosted backup)

[3] Cyramza manufacturer's website

[4] Ramucirumab (Cyramza) patient drug information (Chemocare)

[5] Ramucirumab (Cyramza) patient drug information (UpToDate)

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[2]

[3]

[4]

[5]

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 ==History of changes in FDA indication==
 ===[[:Category:Colorectal_cancers|Colorectal cancer]]===
-* 4/24/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm444496.htm Approved] in combination with [[Colon_cancer#FOLFIRI_.26_Ramucirumab|FOLFIRI]], for the treatment of metastatic [[:Category:Colorectal_cancers|colorectal cancer]] with disease progression on or after prior therapy with [[Bevacizumab (Avastin)|bevacizumab]], [[Oxaliplatin (Eloxatin)|oxaliplatin]], and a fluoropyrimidine. ''(New disease approval)''
+* 4/24/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm444496.htm Approved] in combination with [[Colon_cancer#FOLFIRI_.26_Ramucirumab|FOLFIRI]], for the treatment of metastatic [[:Category:Colorectal_cancers|colorectal cancer]] with disease progression on or after prior therapy with [[Bevacizumab (Avastin)|bevacizumab]], [[Oxaliplatin (Eloxatin)|oxaliplatin]], and a fluoropyrimidine. ''(New disease entity; based on RAISE)''
 ===[[Gastric cancer]]===
-* 4/21/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm394260.htm Initial approval] for the treatment of patients with advanced or metastatic, [[Gastric cancer | gastric or gastroesophageal junction (GEJ) adenocarcinoma]] with disease progression on or after prior treatment with [[Regimen_classes#Fluoropyrimidine-based_regimen|fluoropyrimidine-]] or [[Regimen_classes#Platinum-based_regimen|platinum-]] containing chemotherapy.
+* 4/21/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm394260.htm Initial approval] for the treatment of patients with advanced or metastatic, [[Gastric cancer | gastric or gastroesophageal junction (GEJ) adenocarcinoma]] with disease progression on or after prior treatment with [[Regimen_classes#Fluoropyrimidine-based_regimen|fluoropyrimidine-]] or [[Regimen_classes#Platinum-based_regimen|platinum-]] containing chemotherapy. ''(Based on REGARD)''
-* 11/5/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm421930.htm Approval and indication expanded] for use in combination with [[Paclitaxel (Taxol) | paclitaxel]] for the treatment of patients with advanced [[Gastric cancer | gastric or gastroesophageal junction (GEJ) adenocarcinoma]]. ''(Requirement for prior lines of treatment removed)''
+* 11/5/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm421930.htm Approval and indication expanded] for use in combination with [[Paclitaxel (Taxol) | paclitaxel]] for the treatment of patients with advanced [[Gastric cancer | gastric or gastroesophageal junction (GEJ) adenocarcinoma]]. ''(Requirement for prior lines of treatment removed; based on RAINBOW)''
 ===[[Hepatocellular carcinoma]]===
-* 5/10/2019: Approved as a single agent for [[Hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] in patients who have an [[Biomarkers#AFP|alpha fetoprotein (AFP)]] of at least 400 ng/mL and have been previously treated with sorafenib. ''(New disease approval)''
+* 5/10/2019: Approved as a single agent for [[Hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] in patients who have an [[Biomarkers#AFP|alpha fetoprotein (AFP)]] of at least 400 ng/mL and have been previously treated with sorafenib. ''(New disease entity; based on REACH-2)''
 ===[[Non-small cell lung cancer]]===
-* 12/12/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm426735.htm Approved] for use in combination with [[Docetaxel (Taxotere)|docetaxel]] for the treatment of patients with metastatic [[Non-small cell lung cancer | non-small cell lung cancer (NSCLC)]] with disease progression on or after [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(New disease approval)''
+* 12/12/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm426735.htm Approved] for use in combination with [[Docetaxel (Taxotere)|docetaxel]] for the treatment of patients with metastatic [[Non-small cell lung cancer | non-small cell lung cancer (NSCLC)]] with disease progression on or after [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]. ''(New disease entity; based on REVEL)''
-* 5/29/2020: Approved in combination with erlotinib for first-line treatment of metastatic [[Non-small cell lung cancer | non-small cell lung cancer (NSCLC)]] with [[Biomarkers#EGFR|epidermal growth factor receptor (EGFR)]] [[Biomarkers#Exon_19|exon 19]] [[#Biomarkers_Structural Variant|deletions]] or [[Biomarkers#L858R|exon 21 (L858R) mutations]]. ''(Approval expanded to first-line setting in EGFR+ NSCLC)''
+* 5/29/2020: Approved in combination with erlotinib for first-line treatment of metastatic [[Non-small cell lung cancer | non-small cell lung cancer (NSCLC)]] with [[Biomarkers#EGFR|epidermal growth factor receptor (EGFR)]] [[Biomarkers#Exon_19|exon 19]] [[#Biomarkers_Structural Variant|deletions]] or [[Biomarkers#L858R|exon 21 (L858R) mutations]]. ''(Approval expanded to first-line setting in EGFR+ NSCLC; based on RELAY)''
 ==Also known as==