Deciphera Reports the US FDA’s Acceptance of NDA and Priority Review for Ripretinib to Treat Patients with Advanced Gastrointestinal Stromal Tumors

Deciphera Reports the US FDA’s Acceptance of NDA and Priority Review for Ripretinib to Treat Patients with Advanced Gastrointestinal Stromal Tumors

Shots:

  • The NDA submission is based on P-III INVICTUS study assessing ripretinib vs PBO in 129 patients in a ratio (2:1) with advanced GIST, prior treated with at least imatinib, sunitinib, and regorafenib
  • The P-III INVICTUS study resulted in meeting its 1EPs i.e. improvement in PFS in patients with 4L/4L+ GIST as assessed by RECIST version 1.1. Additionally, Deciphera has submitted MAA in Canada & Australia for ripretinib under FDA’s Project Orbis pilot program and both received PR designation
  • Ripretinib is an investigational broad-spectrum KIT and PDGFRα inhibitor and has received FDA’s FT & BT designation with its anticipated PDUFA date as of of Aug 13, 2020 and is expected to be launch in the US in 2020

Click here to­ read full press release/ article | Ref: Deciphera | Image: Deciphera