Posted by Michael Wonder on 17 Dec 2019
Deciphera Pharmaceuticals announces submission of new drug application to U.S. FDA for ripretinib in patients with advanced gastro-intestinal stromal tumours
16 December 2019 - Application is being reviewed under FDA's real-time oncology review pilot program.
Deciphera Pharmaceuticals today announced the submission of a new drug application to the U.S. FDA for ripretinib, the company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.
In October 2019, FDA granted breakthrough therapy designation for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.
