Deciphera Pharmaceuticals announced the FDA has approved Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. The FDA previously granted Breakthrough Therapy and Fast Track designations as well as Priority Review for Qinlock and reviewed the New Drug Application (NDA) under the Real-Time Oncology Review (RTOR) pilot program.
The Qinlock NDA is also part of Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international health authorities. Qinlock targets the broad spectrum of KIT and PDGFR-alpha mutations known to drive GIST.
The FDA approval was based on efficacy results from the pivotal Phase III INVICTUS study of Qinlock in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of Qinlock. In INVICTUS, Qinlock demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001). In addition, Qinlock demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36).
The most common adverse reactions (at least 20%) were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia syndrome (PPES), and vomiting. Adverse reactions resulting in permanent discontinuation occurred in 8% of patients, dosage interruptions due to an adverse reaction occurred in 24% of patients and dose reductions due to an adverse reaction occurred in 7% of patients who received Qinlock.