FDA approves regorafenib for advanced gastrointestinal stromal tumours
Approval concerns the third line treatment
The USA Food and Drug Administration (FDA) on 25 February 2013 expanded the approved use of regorafenib to treat patients with advanced gastrointestinal stromal tumours (GIST) that can not be surgically removed and no longer respond to other FDA-approved treatments for this disease.
Regorafenib (Stivarga), a multi-kinase inhibitor, blocks several enzymes that promote cancer growth. With this new approval, Stivarga is intended to be used in patients whose GIST tumour can not be removed by surgery or has metastasise and is no longer responding to Gleevec (imatinib) and Sutent (sunitinib), two other FDA-approved drugs to treat GIST. Stivarga is the third drug approved by the FDA to treat GIST.
Stivarga was reviewed under the FDA’s priority review programme, which provides an expedited six-month review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. The drug was also granted orphan product designation because it is intended to treat a rare disease.
The safety and effectiveness of Stivarga for this use were evaluated in a clinical study of 199 patients with GIST that could not be surgically removed and progressed after treatment with Gleevec or Sutent. Patients were randomly assigned to receive either Stivarga or a placebo. All patients also received optimal supportive care, which includes treatments to help manage side effects and symptoms of cancer.
Patients in the study took Stivarga or placebo until either the cancer progressed or the side effects became unacceptable. Results showed patients who took Stivarga had a longer progression-free survival that was, on average, 3.9 months longer than in patients who were given placebo. Patients who received the placebo were given the opportunity to switch to Stivarga when their cancer progressed.
The most common side effects reported in patients treated with Stivarga were weakness and fatigue, hand-foot syndrome, diarrhoea, loss of appetite, high blood pressure, mouth sores, infection, changes in voice volume or quality, pain, weight loss, stomach pain, rash, fever and nausea.
Serious side effects, which occurred in less than one percent of patients, were liver damage, severe bleeding, blistering and peeling of skin, very high blood pressures requiring emergency treatment, heart attacks and perforations in the intestines.
Stivarga was approved by FDA in September 2012 to treat colorectal cancer. It is marketed by Bayer HealthCare Pharmaceuticals.
Sarcoma Patients EuroNet informed on 27 February that it is delighted about FDA approval announcement, which is great news for patients with advanced GIST and means a new option for treatment. Prof Ian Judson, Head of the Sarcoma Unit at the Royal Marsden Hospital, UK and member of the SPAEN Medical Advisory Board commented: "We are delighted to hear that the FDA has approved regorafenib (Stivarga) for 3rd line treatment for patients with advanced GIST. The results of the randomised trial clearly demonstrated the potential of this drug and it represents a valuable addition to treatments available for this group of patients."
The SPAEN stands for Sarcoma Patients EuroNet Association and it is the European Network of Sarcoma, GIST, and Desmoid Patient Advocacy Groups. Acting in partnership with medical experts, scientific researchers, the healthcare industry and other stakeholders, SPAEN works to improve treatment and care of GIST, Desmoid and sarcoma patients in Europe through improving information and support, and by increasing the visibility of sarcoma with policymakers and the public.
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