The QINLOCK New Drug Submission was approved by Health Canada under Project Orbis, an initiative of the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence designed to provide a framework for concurrent submission and review of oncology products among international partners. In May 2020, QINLOCK was approved by the U.S. FDA for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
“Health Canada’s authorization of QINLOCK as part of FDA’s Project Orbis marks an important milestone for GIST patients who have long awaited a new therapeutic option specifically designed to address this complex disease,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “We would like to thank Health Canada for their collaboration during the review process and we look forward to bringing this important new therapy to patients in Canada.”
Health Canada’s authorization was based on efficacy results from the pivotal Phase 3 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 (≥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.
Source: Company Press Release