Qinlock Approved to Treat Gastrointestinal Stromal Tumors

May 15, 2020 – The U.S. FDA has approved QinlockTM (ripretinib), manufactured by Deciphera Pharmaceuticals, to treat adult patients who have advanced gastrointestinal stromal tumor (GIST) and have received prior treatment with three or more kinase inhibitors, including imatinib.

An estimated 4,000 to 6,000 adults are diagnosed with a GIST in the United States annually. The tumors begin in the gastrointestinal tract, most often in the stomach, small intestine, and large intestine. In patients with advanced disease, the five-year survival rate is as low as 52%. Qinlock works by targeting specific mutations known to drive the development of GISTs.

In a clinical trial, patients treated with Qinlock had a median progression-free survival time of 6.3 months, versus one month for patients who received a placebo. Qinlock also reduced the risk of disease progression or death by 85% and delivered a median overall survival time of 15.1 months compared to 6.6 months overall survival and a 64% reduced risk of death on placebo. Recommended dosing is 150mg (three 50mg tablets) taken by mouth once daily with or without food.

Qinlock is available at a wholesale acquisition cost (WAC) of $32,000 per 90 tablets.