Deciphera Pharma files ripretinib at FDA to treat patients with advanced gastrointestinal stromal tumours (GIST).

Deciphera Pharmaceuticals, Inc. announced the submission of a New Drug Application (NDA) to the FDA for ripretinib, the Company�s investigational broad-spectrum KIT and PDGFRalfa inhibitor, for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.

The NDA is being reviewed by the FDA under the Oncology Center of Excellence Real-Time Oncology Review, or RTOR, pilot program. The pilot program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality.

The NDA submission is supported by positive data from the Company�s INVICTUS pivotal Phase III study of ripretinib in advanced GIST. INVICTUS is a randomized (2:1), double-blind, placebo-controlled, international, multicenter study designed to evaluate the efficacy and safety of ripretinib compared to placebo in 129 patients with advanced GIST whose previous therapies have included at least imatinib, sunitinib, and regorafenib. As previously reported, the study achieved the primary endpoint of improved progression free survival compared to placebo in patients with fourth-line and fourth-line plus GIST, as determined by blinded independent central radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1..