Posted by Michael Wonder on 13 Feb 2020
Deciphera Pharmaceuticals announces U.S. FDA acceptance of new drug application and priority review for ripretinib in patients with advanced gastro-intestinal stromal tumour
12 February 2020 - FDA grants priority review and sets PDUFA date of 13 August 2020.
Deciphera Pharmaceuticals today announced that the U.S. FDA has accepted for Priority Review its new drug application seeking approval for ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumours (GIST).
The NDA is being reviewed by the FDA under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) pilot program. This 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. Additional information about RTOR can be found at: https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program.
In addition, the Company has submitted additional marketing applications in Canada and Australia for ripretinib in advanced GIST. These submissions are part of the FDA’s Project Orbis pilot program and both received Priority Review designations. The Project Orbis pilot program, an initiative of the FDA Oncology Center of Excellence, is designed to provide a framework for concurrent submission and review of oncology products among international partners. Additional information about Project Orbis can be found at: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis.
The submission is supported by positive results from the Company’s INVICTUS pivotal Phase 3 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 its 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.
