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