Difference between revisions of "Ramucirumab (Cyramza)"

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m (Text replacement - "==Diseases for which it is established==" to "==Diseases for which it is established ''(work in progress)''==")
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==Diseases for which it is used==
 
==Diseases for which it is used==
−
*[[Bladder cancer]]
 
 
*[[Esophageal adenocarcinoma]]
 
*[[Esophageal adenocarcinoma]]
 +
*[[Urothelial carcinoma]]
  
 
==Patient drug information==
 
==Patient drug information==
−
*[https://chemocare.com/chemotherapy/drug-info/ramucirumab.aspx Ramucirumab (Cyramza) patient drug information (Chemocare)]<ref>[https://chemocare.com/chemotherapy/drug-info/ramucirumab.aspx Ramucirumab (Cyramza) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/ramucirumab.aspx Ramucirumab (Cyramza) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/ramucirumab.aspx Ramucirumab (Cyramza) patient drug information (Chemocare)]</ref>
 
*[http://pi.lilly.com/us/cyramza-pi.pdf Ramucirumab (Cyramza) package insert]<ref name="insert"></ref>
 
*[http://pi.lilly.com/us/cyramza-pi.pdf Ramucirumab (Cyramza) package insert]<ref name="insert"></ref>
 
*[http://www.uptodate.com/contents/ramucirumab-patient-drug-information Ramucirumab (Cyramza) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ramucirumab-patient-drug-information Ramucirumab (Cyramza) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/ramucirumab-patient-drug-information Ramucirumab (Cyramza) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ramucirumab-patient-drug-information Ramucirumab (Cyramza) patient drug information (UpToDate)]</ref>
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==History of changes in FDA indication==
 
==History of changes in FDA indication==
 
===[[Colorectal cancer]]===
 
===[[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 [[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)''
+
* 2015-04-24: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm444496.htm Approved] in combination with [[Colon_cancer#FOLFIRI_.26_Ramucirumab|FOLFIRI]], for the treatment of metastatic [[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]]===
 
===[[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. ''(Based on REGARD)''
+
* 2014-04-21: [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; based on RAINBOW)''
+
* 2014-11-05: [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]]===
 
===[[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 entity; based on REACH-2)''
+
* 2019-05-10: 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]]===
 
===[[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 entity; based on REVEL)''
+
* 2014-12-12: [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; based on RELAY)''
+
* 2020-05-29: 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)''
  
 
==History of changes in EMA indication==
 
==History of changes in EMA indication==
−
*12/16/2014: Initial marketing authorization as Cyramza.
+
*2014-12-16: Initial marketing authorization as Cyramza.
 +
 
 +
==History of changes in Health Canada indication==
 +
*2015-07-16: Initial notice of compliance as a single agent for the treatment of patients with advanced or metastatic [[gastric cancer]] or gastro-esophageal junction adenocarcinoma with disease progression on or after prior platinum and fluoropyrimidine chemotherapy.
 +
*2015-07-16: Initial notice of compliance in combination with paclitaxel for the treatment of patients with advanced or metastatic [[gastric cancer]] or gastro-esophageal junction adenocarcinoma with disease progression on or after prior platinum and fluoropyrimidine chemotherapy.
 +
==History of changes in PMDA indication==
 +
*2015-03-26: Initial approval for the treatment of unresectable advanced or recurrent [[gastric cancer]].
 +
*2016-05-23: New additional indication and a new dosage for the treatment of unresectable advanced or recurrent [[colorectal cancer]].
 +
*2016-06-20: New additional indication and a new dosage for the treatment of unresectable advanced/relapsed [[non-small cell lung cancer]].
 +
*2019-06-18: New indication for the treatment of patients with unresectable [[hepatocellular carcinoma]] whose serum AFP level is greater than 400 ng/mL and conditions have progressed after cancer chemotherapy.
  
 
==Also known as==
 
==Also known as==
−
*'''Code names:''' IMC-1121B, LY3009806
+
*'''Code names:''' IMC-1121B, LY-3009806
 
*'''Brand name:''' Cyramza
 
*'''Brand name:''' Cyramza
  
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[[Category:VEGFR inhibitors]]
 
[[Category:VEGFR inhibitors]]
  
−
[[Category:Bladder cancer medications]]
 
 
[[Category:Colorectal cancer medications]]
 
[[Category:Colorectal cancer medications]]
 
[[Category:Esophageal adenocarcinoma medications]]
 
[[Category:Esophageal adenocarcinoma medications]]
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[[Category:Hepatocellular carcinoma medications]]
 
[[Category:Hepatocellular carcinoma medications]]
 
[[Category:Non-small cell lung cancer medications]]
 
[[Category:Non-small cell lung cancer medications]]
 +
[[Category:Urothelial carcinoma medications]]
  
 
[[Category:EMA approved in 2014]]
 
[[Category:EMA approved in 2014]]
 
[[Category:FDA approved in 2014]]
 
[[Category:FDA approved in 2014]]
−
[[Category:PMDA approved drugs]]
+
[[Category:Health Canada approved in 2015]]
 +
[[Category:PMDA approved in 2015]]

Latest revision as of 13:19, 9 September 2023

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 established (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Colorectal cancer

Gastric cancer

Hepatocellular carcinoma

Non-small cell lung cancer

History of changes in EMA indication

  • 2014-12-16: Initial marketing authorization as Cyramza.

History of changes in Health Canada indication

  • 2015-07-16: Initial notice of compliance as a single agent for the treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with disease progression on or after prior platinum and fluoropyrimidine chemotherapy.
  • 2015-07-16: Initial notice of compliance in combination with paclitaxel for the treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with disease progression on or after prior platinum and fluoropyrimidine chemotherapy.

History of changes in PMDA indication

  • 2015-03-26: Initial approval for the treatment of unresectable advanced or recurrent gastric cancer.
  • 2016-05-23: New additional indication and a new dosage for the treatment of unresectable advanced or recurrent colorectal cancer.
  • 2016-06-20: New additional indication and a new dosage for the treatment of unresectable advanced/relapsed non-small cell lung cancer.
  • 2019-06-18: New indication for the treatment of patients with unresectable hepatocellular carcinoma whose serum AFP level is greater than 400 ng/mL and conditions have progressed after cancer chemotherapy.

Also known as

  • Code names: IMC-1121B, LY-3009806
  • Brand name: Cyramza

References

  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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