Stivarga improved progression-free survival among study patients
The FDA expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed or are metastatic and no longer responding to Gleevec (imatinib) and Sutent (sunitinib), 2 other FDA-approved drugs to treat GIST. Stivarga works by blocking several enzymes that stimulate cancer growth.
Stivarga was reviewed under the FDA’s priority review program.
To determine the safety and effectiveness for this use of Stivarga, researchers conducted a clinical study in 199 patients with GIST. The tumors could not be surgically removed, and, following treatment with Gleevec or Sutent, the disease had progressed. Study participants were randomly assigned to receive either Stivarga or a placebo.
Patients treated with Stivarga, a multikinase inhibitor, experienced a progression-free survival that averaged 3.9 months longer than patients given placebo, according to study results.
The side effects commonly associated with study patients receiving Stivarga included diarrhea, fever, high blood pressure, infection, nausea, weakness and fatigue, palmar-plantar erythrodysesthesia, loss of appetite, mouth sores, changes in voice volume or quality, pain, rash, stomach pain, and weight loss.
The following serious side effects occurred in less than 1% of patients: liver damage, severe bleeding, blistering and peeling of skin, very high blood pressure requiring emergency treatment, heart attack, and perforation in the intestines.
Source: FDA.