MONDAY, May 18, 2020 — The U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as a fourth-line treatment for adults with advanced gastrointestinal stromal tumors (GISTs), the agency announced Friday.
The approval follows four other FDA-approved target therapies for GIST, including imatinib in 2002, sunitinib in 2006, regorafenib in 2013, and avapritinib in January. Qinlock is indicated for patients who have received at least three kinase inhibitor therapies, including imatinib.
Approval of Qinlock was based on data from an international, multicenter, randomized, double-blind, placebo-controlled clinical trial with 129 patients with advanced GIST who had previously received treatment with other targeted therapies. Patients were randomly assigned to receive Qinlock or placebo once a day in 28-day cycles repeated until disease progression or intolerable side effects. Patients whose disease progressed on placebo were given the option of switching to Qinlock. Progression-free survival was an average of 6.3 months for patients who received Qinlock compared with one month for those who received placebo.
The most commonly reported side effects of Qinlock include alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia syndrome, and vomiting. Health providers should routinely check patients being treated with Qinlock for potential serious side effects of skin cancer, hypertension, and cardiac dysfunction manifested as ejection fraction decrease.
Approval was granted to Deciphera Pharmaceuticals.
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Posted: May 2020