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Zai Lab partner Deciphera Pharmaceuticals recently announced that the European Commission (EC) has approved the targeted anti-cancer drug Qinlock (Chinese trade name: Qingle®, generic name: ripretinib, Ripetinib) for fourth-line treatment of gastrointestinal tract GIST (GIST), the drug is specifically applicable to: Adult patients with advanced GIST who have previously received 3 or more kinase inhibitor treatments (including imatinib)
In September 2021, according to the ESMO-EURACAN-GENTURIS clinical practice guidelines, Qinlock was added as the fourth group of GIST patients who received imatinib, sunitinib, and regorafenib but had disease progression or were intolerant to these drugs.
Ripertinib is a KIT/PDGFRα kinase switch regulator inhibitor, used to treat KIT/PDGFRα-driven gastrointestinal stromal tumors (GIST), systemic mastocytosis (SM) and other cancers
This approval is based on the efficacy results of the main analysis of the key phase 3 INVICTUS study, as well as the safety results from the INVICTUS study and the phase 1 study
The main analysis results published in August 2019 showed that the study reached the primary endpoint: Compared with the placebo group, the Qinlock treatment group had significantly longer progression-free survival (median PFS: 6.
The latest analysis results announced at the ESMO meeting in 2020 showed that patients who switched from placebo to open-label Qinlock treatment had a median PFS of 4.
INVICTUS research results
Qinlock's active pharmaceutical ingredient is ripretinib, which is a KIT/PDGFRα kinase switch regulator inhibitor, used to treat KIT/PDGFRα-driven gastrointestinal stromal tumors (GIST), systemic mastocytosis (SM) and other Cancer
In May 2020, Qinlock was approved by the US FDA for the fourth-line treatment of advanced GIST
It is worth mentioning that Qinlock is the first new drug approved for the fourth-line treatment of GIST
Note: The original text has been deleted
Original source: Deciphera Receives European Commission Approval of QINLOCK for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor
