The Scottish Medicines Consortium (SMC) has announced that Stivarga® (regorafenib) has been accepted for use within NHS Scotland for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.1
GIST is the most common form of sarcoma arising from the muscle wall of the gastrointestinal tract.2 GIST represents a life-threatening malignancy if the disease has spread to other parts of the body (metastasised) or is unable to be surgically removed with curative intent.3 GIST affects an estimated 10-20 patients per million per year worldwide.4
Regorafenib has demonstrated a statistically significant improvement in progression-free survival compared to placebo in patients with GIST whose disease had progressed after prior treatments.5
Dr Alexander Moscho, CEO Bayer UK & Ireland said: "This is good news for patients in Scotland with GIST, a rare yet relentless cancer. Patients have limited treatment options and this news means they will now have access to another line of effective therapy. We now hope that for those patients in England with GIST, the Cancer Drugs Fund review will follow Scotland's direction and continue to allow access to this unique treatment in the future."
In clinical trials, the most frequently reported drug-related adverse events in regorafenib-treated patients versus placebo-treated patients, respectively, were: asthenia/fatigue, hand-foot skin reaction (HFSR) / palmar-plantar erythrodysesthesia (PPE), diarrhoea, decreased appetite and food intake, hypertension, mucositis, dysphonia, infection, pain (not otherwise specified), decreased weight, gastrointestinal and abdominal pain, rash, fever and nausea.6