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:

  • advanced gastric cancer (cancer of the stomach) or cancer of the area where the gullet (oesophagus) enters the stomach (known as gastro-oesophageal junction adenocarcinoma). Cyramza is used in combination with another medicine, paclitaxel, or on its own if the combination with paclitaxel is not appropriate, in patients whose disease has worsened despite treatment with medicines containing platinum or fluoropyrimidines (a class of medicines that includes capecitabine, fluorouracil and tegafur);
  • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body). Cyramza is used with ‘FOLFIRI’ chemotherapy (a combination of fluorouracil, folinic acid and irinotecan) in patients whose disease has worsened despite treatment with bevacizumab, oxaliplatin and a fluoropyrimidine;
  • non-small cell lung cancer that is advanced or has spread to other parts of the body. Cyramza is used in combination with docetaxel in patients whose disease has worsened despite treatment with medicines containing platinum;
  • hepatocellular carcinoma (a type of liver cancer) that is advanced or cannot be removed with surgery. Cyramza is used on its own in patients with a high blood level of a protein called alpha fetoprotein (AFP) and who have been previously treated with sorafenib.

Cyramza contains the active substance ramucirumab.

This EPAR was last updated on 28/11/2019

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

26/09/2019 Cyramza - EMEA/H/C/002829 - R/0031

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

How useful was this page?

Add your rating