FDA grants priority review and sets PDUFA date for Deciphera's GIST candidate

Tumor drug resistance specialist Deciphera Pharmaceuticals (Nasdaq: DCPH) yesterday revealed that the US Food and Drug Administration has accepted for priority review its New Drug Application (NDA) seeking approval for ripretinib, the company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST).

The FDA granted Priority Review for the NDA, which provides for a six-month review, and assigned a Prescription Drug User Fee Act (PDUFA) target action 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 of Deciphera, adding: “With commercial preparations already underway, we believe we will be well positioned for a potential US launch in 2020. We look forward to working with the FDA during their review of this application.”