Korea approves QINLOCK for fourth-line GIST treatment

The food and drug safety ministry said Friday it approved the imported rare-disease drug QINLOCK 50mg (ripretinib) for adults with advanced gastrointestinal stromal tumors who have already been treated with at least three kinase inhibitors, including imatinib.

The approval gives patients whose disease has stopped responding to existing therapies a fourth-line treatment option, the ministry said. Ripretinib is a tyrosine kinase inhibitor, and GIST arises in the tissue that forms the walls of the stomach and intestines. The ministry said the treatment is expected to offer a new therapeutic opportunity for patients who do not respond to existing medicines.

The review was fast-tracked under the ministry's Global Innovative product on Fast Track, or GIFT, system, which is designed to speed up assessment of treatments for life-threatening or rare diseases that show strong innovation. QINLOCK 50mg was designated the 55th product under the program before approval.

The ministry said it will continue working to ensure treatments with sufficiently confirmed safety and efficacy are reviewed and approved quickly so that patients have broader access to treatment, drawing on its expertise in regulatory science.