Swissmedic Approves QINLOCK by Deciphera for Fourth-Line Treatment of Gastrointestinal Stromal Tumor

  • Worldwide, this is the seventh approval for QINLOCK. 
  • In Europe, it is the first approval for this medicine.
  • Swissmedic, the Swiss Agency for Therapeutic Products, has approved QINLOCK (ripretinib) for Fourth-Line Treatment of Gastrointestinal Stromal Tumor.

On October 12, 2021, Deciphera Pharmaceuticals, Inc. announced that the Swissmedic or the Swiss Agency for Therapeutic Products has granted approval to QINLOCK (ripretinib) for the fourth-line treatment of those adult patients diagnosed with Gastrointestinal Stromal Tumor who have already received three or more prior therapies for the condition, including Imatinib.

The efficacy results from the primary analysis of the pivotal Phase 3 INVICTUS study of QINLOCK in adult patients suffering from advanced GIST, as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK, were used to support the application for QINLOCK authorization. QINLOCK significantly decreased the risk of disease progression or death by 85 percent in INVICTUS, with a median progression-free survival of 6.3 months compared to one month in the placebo arm.

Objective Response Rate (ORR) and Overall Survival (OS) are secondary endpoints established by independent radiologic evaluation using modified RECIST. QINLOCK had an ORR of 9.4% compared to 0% for placebo. Furthermore, the medication had a median overall survival of 15.1 months compared to 6.6 months in the placebo arm, and it reduced the chance of mortality by 64%.

Fatigue, weight loss, vomiting, myalgia, constipation, diarrhea, palmar-plantar erythrodysesthesia syndrome (PPES), alopecia, nausea, arthralgia, headache, lipase elevation, muscular spasms, and dyspnoea were the most common adverse events in patients treated with QINLOCK.

QINLOCK is a switch-control tyrosine kinase inhibitor that uses a dual method of action to block KIT and PDGFRA mutant kinases. It works by regulating the kinase switch pocket and activation loop. QINLOCK suppresses main and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, as well as the primary exon 17 D816V mutations, which are linked to GIST. 

View full prescribing information for QINLOCK (ripretinib).