FDA Approves Deciphera’s Qinlock for Gastrointestinal Stromal Tumor
The FDA approved Decipharma Pharmaceuticals’ Qinlock (ripretinib) as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST).
The approval was based on the results of a study of 129 patients with advanced GIST who received prior treatment with imatinib, sunitinib, and regorafenib.
Progression-free survival in participants taking Qinlock was 6.3 months, compared to one month for those taking placebo.
Qinlock was granted priority review, fast track, and breakthrough therapy designations.