What is Cyramza and what is Ramucirumab used for?
Cyramza is an anticancer medicine used in the treatment of adult patients with advanced gastric cancer (tumors of the stomach) or with a tumor localized in the tract where the esophagus joins the stomach (called the adenocarcinoma of the gastroesophageal junction). Cyramza is used in combination with another medicine, paclitaxel, when the disease has worsened despite treatment with platinum and fluoropyrimidine medicines. In subjects in whom the disease has progressed despite platinum or fluoropyrimidine therapy, Cyramza can be given as monotherapy (alone) if treatment in combination with paclitaxel is not appropriate Cyramza contains the active substance ramucirumab . Because the number of patients with gastric cancer is low, the disease is considered 'rare' and Cyramza was designated an 'orphan medicine' (a medicine used in rare diseases) on 4 July 2012.
How is Cyramza used - ramucirumab?
Cyramza is available as a concentrate for solution for infusion (drip into a vein). The medicine can only be obtained with a prescription and treatment should be started and conducted under the supervision of a doctor who is experienced in treating cancer. If Cyramza is used in combination with paclitaxel, the recommended dose is 8 mg per kg of body weight, to be administered on days 1 and 15 of a 28-day cycle, before the infusion of paclitaxel (which is expected on days 1, 8 and 15). If Cyramza is used on its own, the recommended dose is 8 mg per kg of body weight to be given every two weeks. For more information, see the package leaflet.
How does Cyramza - ramucirumab work?
The active substance in Cyramza, ramucirumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) developed to recognize and bind to a specific structure (the antigen) present in the body. Ramucirumab was designed to bind to a protein receptor called vascular endothelial growth factor (VEGF). The VEGF receptor may be present in high concentrations in gastric tumors, where it contributes to the formation of new blood vessels supplying the tumor mass. By binding to this receptor, ramucirumab blocks its action, reducing the blood supply to the tumor and slowing its growth. Cyramza is produced by a method known as "recombinant DNA technique"; that is, it is obtained from cells in which a gene (DNA) has been introduced that allows them to produce ramucirumab.
What benefit has Cyramza - ramucirumab shown during the studies?
Cyramza used in combination with paclitaxel has been shown to improve the survival of patients with advanced gastric carcinoma or adenocarcinoma of the gastro-oesophageal junction, in progression during or after platinum and fluorpirimidine therapy. In a main study involving 665 patients, subjects treated with Cyramza and paclitaxel survived on average for a significantly longer period of time than patients treated with paclitaxel and placebo (a dummy treatment): 9.6 months compared to 7, 4 months. Similarly, in another study of 355 patients, subjects treated with Cyramza in combination with the best supportive care were significantly longer than patients treated with placebo and the best supportive care (on average, 5.2 months compared to 3.8 months).
What is the risk associated with Cyramza - ramucirumab?
The most common side effects of Cyramza (which may affect more than 1 in 10 people) are fatigue or asthenia (weakness), leukopenia (decrease in the number of white blood cells), neutropenia (decrease in a particular type of white blood cell), diarrhea, epistaxis (bleeding from the nose) and hypertension (high blood pressure). The most serious side effects reported (with Cyramza used alone or in combination with paclitaxel) were gastrointestinal perforation (a hole forming in the intestinal wall), severe gastrointestinal bleeding (bleeding from the intestine) and arterial thromboembolic events (problems caused by blood clots and obstruction of the arteries). For the full list of all side effects and restrictions with Cyramza, see the package leaflet.
Why has Cyramza - ramucirumab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cyramza's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP is of the opinion that the benefit of Cyramza in prolonging the life of patients with gastric cancer and adenocarcinoma of the gastroesophageal junction has been clearly demonstrated with the use of Cyramza in combination with paclitaxel. The benefit is lower when Cyramza is used on its own, but the use of the medicine may continue to be a therapeutic option when treatment with paclitaxel is not considered appropriate. The magnitude of benefit is considered clinically relevant in light of the usually poor prognosis of these patients. The safety profile of ramucirumab is in line with what is expected for other medicines that block the activity of the VEGF receptor and is considered acceptable, if the benefits offered by the medicine are taken into account.
What measures are being taken to ensure the safe and effective use of Cyramza - ramucirumab?
A risk management plan has been developed to ensure that Cyramza is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cyramza, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Cyramza - ramucirumab
On 19 December 2014, the European Commission issued a marketing authorization for Cyramza, valid throughout the European Union. For more information about treatment with Cyramza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The summary of the opinion of the Committee for Orphan Medicinal Products related to Cyramza is available on the Agency's website: ema.Europa.eu/Find medicine / Human medicines / Rare disease designation. Last update of this summary: 01-2015.
