Deciphera Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for ripretinib for Priority Review. Ripretinib is an investigational broad-spectrum KIT and PDGFRa inhibitor for the treatment of patients with gastrointestinal stromal tumors (GIST). Priority Review provides for a six-month review. A targeted action date for this is August 13, 2020.
“With commercial preparations already underway, we believe we will be positioned for a potential U.S. Launch in 2020. We look forward to working with the FDA during the review of this application.” – Steve Hoerter, President and Chief Executive Officer, Deciphera
The Life Raft Group looks forward to continued collaboration with Deciphera, and to assisting in helping GIST patients to survive and thrive.
Full article “FDA Grants Priority Review to Deciphera’s Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors” appears in Specialty Pharma Journal.