The United States Food and Drug Administration has approved Qinlock (ripretinib) for treating the patients suffering from advanced gastrointestinal stromal tumour (GIST), as a fourth-line therapy. The drug is indicated in patients who were prior treated with three kinase inhibitors including imatinib.
GIST usually impacts stomach, small intestine, and large intestine, and currently effecting 4,000 to 6,000 patients in the US every year. Qinlock is also a kinase inhibitor.
The approval of the drug is based on multi-center, randomized, double-blind, placebo-controlled clinical trial, enrolled 129 patients. The patients were prior treated with imatinib, sunitinib and regorafenib. Progression free survival of Qinlock (ripretinib) is 6.3 months compared to one month in placebo group.
Common side effects with the product are alopecia (hair loss), fatigue, nausea, abdominal pain, constipation, myalgia (muscle pain), diarrhea, decreased appetite, and vomiting.
The product has received Priority review, Fast track and breakthrough designation. In addition the product has also received orphan designation.
The application of the drug is under review in Australia and Canada.