Cyramza

RSS

ramucirumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Cyramza is a cancer medicine used to treat adult patients with:

  • gastric cancer (cancer of the stomach) or cancer of the area where the gullet (oesophagus) enters the stomach (known as gastro-oesophageal junction adenocarcinoma);
  • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body);
  • non-small cell lung cancer that has spread to other parts of the body or in patients whose cancer involves mutations (changes) in proteins called endothelial growth factor receptors (EGFRs);
  • hepatocellular carcinoma (a type of liver cancer) in patients with a high blood level of a protein called alpha fetoprotein (AFP).

Cyramza is for use in cancers that are usually advanced or have spread despite other treatment.  For most cancers it is used in combination with other medicines.

For detailed information on the use of Cyramza in all conditions, see the package leaflet or contact your doctor or pharmacist.

Cyramza contains the active substance ramucirumab.

This EPAR was last updated on 25/02/2020

Authorisation details

Product details
Name
Cyramza
Agency product number
EMEA/H/C/002829
Active substance
Ramucirumab
International non-proprietary name (INN) or common name
ramucirumab
Therapeutic area (MeSH)
Stomach Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
19/12/2014
Contact address

Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

23/01/2020 Cyramza - EMEA/H/C/002829 - II/0033

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Gastric cancer

Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy.

Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.

Colorectal cancer

Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5‑fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.

Non-small cell lung cancer

Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.

Hepatocellular carcinoma

Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with sorafenib.

Assessment history

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