On May 15, the FDA approved ripretinib tablets (Qinlock) as a fourth-line treatment for adult patients with advanced GI stromal tumors.
The kinase inhibitor is indicated for those who have received prior treatment with three or more kinase inhibitor therapies, including imatinib. Approval was based on results of a randomized trial of 129 patients. Participants who received the drug had an average progression-free survival of 6.3 months, compared to one month among those who received placebo.
The most common side effects were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia syndrome, and vomiting. The orphan drug can cause serious side effects, including skin cancer, hypertension, and cardiac dysfunction manifested as ejection fraction decrease.