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Stivarga for treatment of metastatic colorectal cancer

Stivarga is an anticancer medicine that contains the active substance Regorafenib. It is used to treat metastatic colorectal cancer in adults who have already been treated with, or who cannot be given, other available treatments.

Stivarga is available as tablets ( 40 mg ). It is taken in 4-week treatment cycles at a recommended starting dose of 160 mg once every day for three weeks, followed by a week off. Doses should be taken at the same time each day with a light meal. Treatment should continue for as long as possible, until the disease worsens or the side effects become too severe. Treatment may need to be interrupted or stopped, or the dose reduced, if the patient experiences certain side effects.

The active substance in Stivarga, Regorafenib, is a protein kinase inhibitor. This means that it blocks several enzymes that are important for the development of a blood supply to tumours and the growth and development of cancer cells. By blocking the action of these enzymes, Stivarga helps to restrict the growth and spread of the cancer.

Stivarga has been studied in one main study involving 760 patients with metastatic colorectal cancer which had progressed after standard therapy. The study compared Stivarga with placebo and the main measure of effectiveness was overall survival. All patients also received supportive care, including pain medicines and treatment for infections and low blood-cell counts. The study showed that Stivarga improved survival, with treated patients living for 196 days on average, compared with 151 days for those given placebo.

The most common side effects with Stivarga ( which may affect more than 3 in 10 people ) are weakness, tiredness, loss of appetite and eating less, hand-foot syndrome ( rash and numbness affecting the palms and soles ), diarrhoea, weight loss, infection, hypertension and dysphonia. The most serious side effects are severe liver injury, bleeding and gastrointestinal perforation.

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 European Union ( EU ). The Committee noted that the benefits in terms of extending patient survival were modest, but considered that they outweighed the risks in patients for whom there are no other remaining treatment options. However, given the side effects, the CHMP considered it important to find ways to identify any subgroups of patients who are more likely to respond to Stivarga. ( Xagena )

Source : European Medicines Agency ( EMA ), 2013