Research & Development
European Medicines Committee Issues Positive Opinion for Qinlock for the Treatment of Fourth-line Gastrointestinal Stromal Tumor
20 September 2021 - - The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with three or more kinase inhibitors, including imatinib, US-based biopharmaceutical company Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) said.

The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission, which has the authority to approve medicines in the European Union, issues a decision on Deciphera's marketing authorization application for ripretinib.

The MAA is supported by 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, ripretinib 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


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