FDA grants priority review to ripretinib for advanced gastrointestinal stromal tumors
The FDA granted priority review to ripretinib for treatment of advanced gastrointestinal stromal tumors, according to a press release from the agent’s manufacturer.
Ripretinib (Deciphera Pharmaceuticals) is a tyrosine kinase switch control inhibitor engineered to broadly inhibit KIT and platelet-derived growth factor receptor alpha-mutated kinases.
The FDA previously granted fast track and breakthrough therapy designations to the agent for use by patients with previously treated advanced gastrointestinal stromal tumors (GIST).
The agency is expected to make a decision on the new drug application for ripretinib by Aug. 13.
The application includes data from the randomized phase 3 INVICTUS study, which included 129 patients with advanced GIST who underwent prior treatment with imatinib, sunitinib (Sutent, Pfizer) and regorafenib (Nexavar, Bayer).
The double-blind, multicenter study achieved its primary endpoint, as patients assigned ripretinib as fourth-line or later treatment achieved significantly longer PFS than those assigned placebo.
“The FDA’s acceptance of our new drug application brings us one step closer to our goal of providing patients with advanced GIST a potential new treatment option,” Steve Hoerter, president and CEO of Deciphera, said in the press release. “With commercial preparations already underway, we believe we will be well-positioned for a potential U.S. launch in 2020. We look forward to working with the FDA during their review of this application.”
The FDA is reviewing the new drug application under the Oncology Center of Excellence Real-Time Oncology Review pilot program, intended to evaluate a more efficient review process in hopes of maintaining review quality while ensuring effective and safe therapies are made available to patients as soon as possible.