“The Breakthrough Therapy Designation reflects the substantial clinical benefit of QINLOCK in second-line GIST patients harboring mutations in KIT exon 11 and 17/18 that we observed in the ctDNA analysis from the INTRIGUE Phase 3 study. If approved, we believe QINLOCK has the potential to become the standard-of-care for this group of second-line GIST patients around the world. GIST key opinion leaders and physicians have long been proponents of clinical drug development targeted at specific molecular subtypes of GIST, and we are pleased with the FDA’s recognition that the ctDNA data indicates QINLOCK may demonstrate substantial improvement over the current standard-of-care in this population,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. “Further, the inclusion of QINLOCK in the latest NCCN clinical practice guidelines underscores both the need for additional treatment options for GIST patients in the post-imatinib setting and the significance of the results from the INTRIGUE study, which demonstrated that QINLOCK is an active and well-tolerated agent.”
