What is Stivarga - Regorafenib and what is it used for?
Stivarga is an anticancer medicine that contains the active substance regorafenib . It is used to treat the following types of cancer:
- colorectal tumor (cancer of the intestine and rectum) that has spread to other parts of the body;
- Gastrointestinal stromal tumor (GIST, a cancer of the stomach and intestines) that has spread and cannot be surgically removed.
Stivarga is used in patients who have already undergone treatment or who cannot be treated with available therapies. For colorectal cancer these include chemotherapy based on drugs called fluoropyrimidines and treatment with other anticancer drugs known as drugs for anti-VEGF and anti-EGFR therapies. Patients with GIST will have tried to be treated with imatinib and sunitinib.
How is Stivarga - Regorafenib used?
Treatment with Stivarga should be prescribed by doctors who specialize in treating cancer. The medicine can only be obtained with a prescription. Stivarga is available as tablets (40 mg). It is taken in therapeutic cycles of 4 weeks at the recommended starting dose of 160 mg once a day for 3 weeks, followed by 1 week without therapy. Doses should be taken at the same time every day, with a light meal. Treatment should continue as long as possible, until the disease gets worse or until the side effects are unacceptable. If the patient complains of some side effects it may be necessary to suspend or stop the therapy or reduce the dose. For more information, see the package leaflet.
How does Stivarga - Regorafenib work?
The active substance in Stivarga, regorafenib, is a "protein kinase inhibitor". That is, it blocks some enzymes that are important to ensure the blood supply to the tumor as well as the growth and proliferation of cancer cells. By blocking the action of these enzymes, Stivarga helps to limit the growth and spread of the tumor
What benefit has Stivarga - Regorafenib shown during the studies?
In one main study involving 760 patients with metastatic colorectal cancer, which had progressed after standard therapy, Stivarga was compared with a placebo (a dummy treatment) and the main measure of effectiveness was overall survival of patient (the patient's life span). All patients also received supportive care, including painkillers and a therapy to fight infections and low blood cell counts. Studies have shown that Stivarga has improved patient survival: subjects treated with the medicine lived on average 196 days compared to 151 days in subjects treated with placebo. In another main study, Stivarga was compared to a placebo. This study was attended by 199 patients with GIST who had progressed or were not surgically operable, who also received the best supportive care. Supportive care included treatments such as pain therapy, antibiotics and blood transfusions that help the patient but do not cure the tumor. The study demonstrated the effectiveness of Stivarga associated with supportive care in prolonging patients' life time without their illness getting worse. Patients treated with Stivarga lived on average 147 days without their disease getting worse, compared to 28 days for those taking placebo and supportive care.
What is the risk associated with Stivarga - Regorafenib?
The most common side effects of Stivarga (which may affect more than 3 in 10 people) are weakness, fatigue, decreased appetite and food intake, hand-foot syndrome (skin reaction and numbness of the palm of the hand and the plant of the foot), diarrhea, infection, hypertension (increase in blood pressure) and dysphonia (alterations of the voice). The most serious side effects are significant liver damage, haemorrhage and gastrointestinal perforation (a continuity solution in the intestinal wall). For the full list of all side effects reported with Stivarga, see the package leaflet.
Why has Stivarga - Regorafenib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Stivarga's benefits are greater than its risks and recommended that it be approved for use in the EU. The committee noted that, in colorectal cancer, the benefits in terms of increased patient survival were modest, but considered that they were higher than the risks in patients for whom there are no other treatment options. However, in view of the undesirable effects, the CHMP considered it important to find ways to identify any subgroups of patients most likely to respond to Stivarga.
Regarding subjects with GIST, the committee noted that the prospects are unsatisfactory for those subjects in whom a worsening of the disease was detected despite treatment with imatinib and sunitinib. In these patients, Stivarga has been shown to delay the worsening of the disease and its side effects are manageable.
What measures are being taken to ensure the safe and effective use of Stivarga - Regorafenib?
A risk management plan has been developed to ensure that Stivarga 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 Stivarga, including the appropriate precautions to be followed by healthcare professionals and patients. The company that markets Stivarga will also carry out studies to identify those most likely to respond to the treatment.
More information on Stivarga - Regorafenib
On 26 August 2013, the European Commission issued a marketing authorization for Stivarga, valid throughout the European Union. For more information about Stivarga therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 07-2014.
