Posted by Michael Wonder on 19 Mar 2023
Deciphera Pharmaceuticals announces FDA grants breakthrough therapy designation for Qinlock in second-line GIST patients with mutations in KIT exon 11 and 17/18
14 March 2023 - Breakthrough therapy designation is based on results from ctDNA analysis of INTRIGUE Phase 3 clinical trial demonstrating substantial clinical benefit of Qinlock in second-line GIST patients with mutations in KIT exon 11 and 17/18.
Deciphera Pharmaceuticals announced that the US FDA has granted breakthrough therapy designation for Qinlock for the treatment of adult patients with unresectable or metastatic GIST who received prior treatment with imatinib, and who harbour a KIT exon 11 mutation and co-occurring KIT exon 17 and/or 18 mutations (KIT exon 11+17/18 mutations).
