Drug

CYRAMZA®

ramucirumab

Cyramza 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.

Cyramza is given by infusion (drip) into a vein. It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the treatment of cancer.

The dose of Cyramza and how often it is given depends on the patient’s weight and the condition being treated.

Treatment should continue for as long as the patient benefits from it. For more information about using Cyramza, see the package leaflet or contact your doctor or pharmacist.

The active substance in Cyramza, ramucirumab, is a monoclonal antibody (a type of protein) designed to attach to vascular endothelial growth factor receptor (VEGFR), a protein present at high levels in tumours. VEGFRhelps in the development of new blood vessels that supply the tumours. By attaching to VEGFR, ramucirumab blocks this action, reducing the blood supply to the tumour and so slowing the growth of the cancer.

Cyramza increased survival of patients with advanced gastric or gastro-oesophageal junction cancer, metastatic colorectal cancer, advanced or metastatic non-small cell lung cancer and hepatocellular carcinoma in 5 main studies.

In one main study involving 665 patients with advanced gastric or gastro-oesophageal junction cancer which worsened despite treatment with medicines containing platinum and a fluoropyrimidine, those treated with Cyramza and paclitaxel lived longer than patients receiving paclitaxel and placebo (a dummy treatment): on average 9.6 months versus 7.4 months respectively. Similarly, in another study in 355 patients, those treated with Cyramza plus best supportive care lived longer than patients receiving placebo plus best supportive care (an average of 5.2 months versus 3.8 months, respectively).

In a main study involving 1,072 patients with metastatic colorectal cancer which worsened despite treatment with bevacizumab, oxaliplatin and a fluoropyrimidine, those treated with Cyramza and FOLFIRI lived longer than patients receiving FOLFIRI and placebo: on average 13.3 months versus 11.7 months respectively.

In a main study involving 1,253 patients with advanced or metastatic non-small cell lung cancer which worsened despite treatment with medicines containing platinum, those treated with Cyramza and docetaxel lived longer than patients receiving docetaxel and placebo: on average 10.5 months versus 9.1 months respectively.

In a study involving 292 patients with hepatocellular carcinoma that is advanced or cannot be removed with surgery and who have high AFP blood level and have been previously treated with sorafenib, patients receiving Cyramza lived longer than those receiving placebo: 8.5 versus 7.3 months, respectively.

The European Medicines Agency decided that Cyramza’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency noted that Cyramza prolonged the lives of patients with gastric and gastro-oesophageal junction cancer when it was given with paclitaxel. The benefit was smaller when Cyramza was given on its own, but this could still be an option when treatment with paclitaxel is not considered appropriate. Cyramza also prolonged survival of patients with colorectal cancer, non-small cell lung cancer and hepatocellular carcinoma. Although the effects were modest, the size of the benefit was considered clinically relevant given the normally poor prognosis in these patients.

The safety profile of Cyramza is in line with that expected for other medicines blocking VEGFR activity and is considered manageable.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cyramza have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Cyramza is continuously monitored. Side effects reported with Cyramza are carefully evaluated and any necessary action taken to protect patients.

Cyramza received a marketing authorisation valid throughout the EU on 19 December 2014.

What are the risks associated with Cyramza?

The most common side effects with Cyramza (which may affect more than 1 in 10 people) include tiredness or weakness, leucopenia (low white blood cell counts), neutropenia (low counts of a particular type of white blood cell), diarrhoea, nosebleeds and stomatitis (inflammation of the lining of the mouth). The most serious adverse effects reported (either of Cyramza alone or in combination with other cancer medicines) included gastrointestinal perforation (a hole that develops in the wall of the gut), severe gastrointestinal haemorrhage (bleeding from the gut) and arterial thromboembolic events (problems caused by blood clots and blockage of the arteries). 

When used for lung cancer, Cyramza must not be used when there is a cavity in the cancer or if the cancer is close to a major blood vessel. 

Owner of copyright and other intellectual property rights to European Medicines Agency

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