The FDA granted priority review to a new drug application (NDA) seeking approval of ripretinib to treat patients with advanced gastrointestinal stromal tumors (GIST), according to a Deciphera Pharmaceuticals, Inc. news release.1
The 6-month review replaces the FDA’s standard 10-month review process, which also assigned the NDA with a Prescription Drug User Fee Act (PDUFA) date of August 13, 2020.
“The FDA’s acceptance of our NDA brings us one step closer to our goal of providing patients with advanced GIST a potential new treatment option,” said Steve Hoerter, president and chief executive officer of Deciphera, in a news 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 NDA is supported by the positive results from the INVICTUS phase III study of ripretinib in advanced GIST. The randomized, double-blind, placebo-controlled, multicenter study evaluated 129 patients with advanced GIST for the efficacy and safety of ripretinib compared to a placebo. The primary endpoint of the study was improved progression-free survival.
The priority review process is considered for drugs that “would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.” The NDA is being reviewed under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) pilot program that focuses on streamlining the review process with the goal of getting patients safe and effective treatment as soon as possible without compromising the quality of the review.
Riptretinib is an investigational broad-spectrum KIT and PDGFRα inhibitor that previously received breakthrough therapy designation.
Advanced GIST is a rare type of tumor, accounting for less than 1% of all gastrointestinal tumors, according to the American Society of Clinical Oncology. Moreover, about 60% of GISTs begin in the stomach, while approximately 35% begin in the small intestine.2
1. Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors. Waltham, Massachusetts. Published February 12, 2020. https://investors.deciphera.com/news-releases/news-release-details/deciphera-pharmaceuticals-announces-us-food-and-drug. Accessed February 13, 2020.
2. American Society of Clinical Oncology. Gastrointestinal Stromal Tumor - GIST: Statistics. Cancer.net. https://www.cancer.net/cancer-types/gastrointestinal-stromal-tumor-gist/statistics. Published January 1, 2019. Accessed February 13, 2020.