The regulatory authorisation indicated Qinlock for the treatment of advanced gastrointestinal stromal tumour in adult patients who received prior treatment with imatinib, sunitinib and regorafenib
Deciphera Pharmaceuticals has received Health Canada authorisation for Qinlock (ripretinib), a switch-control tyrosine kinase inhibitor designed to treat a type of stomach cancer.
The regulatory authorisation indicated Qinlock for the treatment of advanced gastrointestinal stromal tumour (GIST) in adult patients who received prior treatment with imatinib, sunitinib and regorafenib.
Qinlock is a tyrosine kinase switch control inhibitor designed to inhibit KIT and PDGFRα mutated kinases by leveraging a dual mechanism of action that regulates the kinase switch pocket and activation loop.
Deciphera president and chief executive officer Steve Hoerter said: “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.
“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 authorisation for Qinlock is based on Phase 3 INVICTUS study
The biopharmaceutical company has secured the US FDA approval for Qinlock in May 2020, to treat advanced GIST in adults who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Health Canada has approved the company’s New Drug Submission for Qinlock under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence to facilitate a framework for synchronised submission and review of oncology products among international partners.
In addition, the current authorisation was supported by the results from Phase 3 INVICTUS study of Qinlock in patients with advanced GIST, combined with safety results from INVICTUS and the Phase 1 study of Qinlock.
In the clinical study, the drug has shown a median progression-free survival compared to the placebo arm and reduced the risk of disease progression or death.
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 include alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhoea, decreased appetite, palmar-plantar erythrodysesthesia syndrome (PPES), and vomiting.