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Qinlock

Brand: 再鼎医药
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Ripretinib Instructions

Generic name: Ripretinib
Trade name: Qinlock
Full names: Ripretinib, Ripretinib, Qinlock


Indications:
For the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have been treated with three or more lysine kinase inhibitors (TKIs) including imatinib.


Usage and dosage:
150 mg, taken orally once a day, with food or on an empty stomach.


Adverse reactions:
Nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation, fatigue, muscle pain, thinning hair, hair loss, abnormal blood tests, severe rash on hands or feet< /p>


Contraindications:
Unclear


Precautions:
Ripatinib may affect male fertility, thereby affecting fertility.
Sometimes it is not safe to use certain drugs together. Some medicines may affect the blood levels of other medicines you take, which may increase side effects or make the medicines less effective. Tell your doctor about any other medicines you are taking before taking it.


Storage:
Store at room temperature.


Mechanism of action:
Repetinib is a tyrosine kinase switch-controlled inhibitor that regulates the kinase switch and activation loop through a unique dual mechanism of action, thereby broadly inhibiting KIT and PDGFRα mutant kinases.


Safety and efficacy:
The INVICTUS study is a double-blind, randomized, placebo-controlled phase III clinical study. In the double-blind phase of the study, patients with advanced GIST who had previously received at least imatinib, sunitinib, and regorafenib were randomized in a 2:1 ratio to receive 150 mg of repetinib once daily or placebo. After the blinded independent review center determines that the patient's disease has progressed, the study will enter the open study phase. Patients in the placebo group can cross over to the repetinib 150 mg once daily group for treatment after disease progression. The primary endpoint of the study is PFS assessed according to MRECIST1.1 standards, and secondary endpoints include overall survival (OS), investigator-assessed PFS, quality of life (QOL), and safety.
INVICTUS results showed that the median PFS of repetitinib was 6.3 months, while the median PFS of the placebo group was 1.0 months. Further analysis of patients in the placebo group who crossed over to receive repetinib treatment and those who did not receive repetinib treatment showed that crossover treatment can bring significant OS benefits, with OS in the two groups being 11.6 months and 1.8 months respectively.