
Japanese drugmaker Ono Pharmaceutical (TYO: 4528) announced it has submitted an application for the manufacturing and marketing approval in Japan of ripretinib (DCC-2618), developed by Deciphera Pharmaceuticals (Nasdaq: DCPH) for the indication of gastrointestinal stromal tumor (GIST) that has progressed following cancer chemotherapy.
This application is based on the results of the INVICTUS study, a global Phase III clinical study, evaluating the efficacy of ripretinib compared to placebo in patients with advanced gastrointestinal stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib. In this study, ripretinib significantly prolonged the primary endpoint of progression-free survival (PFS) compared to placebo.
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