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Deciphera says FDA grants breakthrough therapy designation for QINLOCK
The Fly

Deciphera says FDA grants breakthrough therapy designation for QINLOCK

Deciphera Pharmaceuticals announced that QINLOCK has been included in the latest National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a preferred regimen for second-line gastrointestinal stromal tumor patients intolerant to sunitinib. The company also announced that the U.S. Food and Drug Administration 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 harbor a KIT exon 11 mutation and co-occurring KIT exon 17 and/or 18 mutations. QINLOCK is Deciphera’s switch-control inhibitor currently approved in 12 territories around the world, including major markets of the United States, Europe, and China for the treatment of fourth-line GIST. "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."

Published first on TheFly

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