Basic Information
L01
抗肿瘤药
Antineoplastic agents
Therapeutic indication
Qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.
Overview Summary
Qinlock is a cancer medicine used to treat gastrointestinal stromal tumour (GIST), a cancer of the stomach and bowel, in adults with advanced disease who have already been treated with three or more medicines of the ‘kinase inhibitor’ class, including a medicine called imatinib.
GIST is rare, and Qinlock was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 12 October 2017.
Qinlock contains the active substance ripretinib.
Active Substances (2)
ripretinib
ripretinib
Documents (12)
Qinlock-H-C-PSUSA-00010962-202205 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
May 30, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Qinlock : EPAR - Public assessment report
November 23, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Qinlock : EPAR - Risk-management-plan summary
November 23, 2021
RISK_MANAGEMENT_PLAN_SUMMARY
Qinlock : EPAR - Procedural steps taken and scientific information after authorisation
December 13, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Qinlock : EPAR - Product information
November 23, 2021
DRUG_PRODUCT_INFORMATION
CHMP summary of positive opinion for Qinlock
September 17, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Qinlock : Orphan maintenance assessment report (initial authorisation)
November 23, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Qinlock : EPAR - Public assessment report
November 23, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Qinlock : Orphan maintenance assessment report (initial authorisation)
November 23, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Qinlock
September 17, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Qinlock : EPAR - Medicine overview
November 23, 2021
OVERVIEW_DOCUMENT
Qinlock : EPAR - All authorised presentations
November 23, 2021
AUTHORISED_PRESENTATIONS
Overview Q&A (7)
Question
Why is Qinlock authorised in the EU?
Answer
Qinlock was shown to be effective at slowing down the progress of the disease in patients with GIST who had been treated with at least three other medicines. Qinlock was shown to have a favourable safety profile with manageable side effects.
The European Medicines Agency therefore decided that Qinlock’s benefits are greater than its risks and it can be authorised for use in the EU.
Question
What are the risks associated with Qinlock?
Answer
The most common side effects with Qinlock (which may affect more than 1 in 4 people) are tiredness, hair loss, nausea (feeling sick), muscle pain, constipation, diarrhoea, palmar-plantar erythrodysaesthesia syndrome (PPES, rash and numbness on the palms and soles), weight loss and vomiting.
For the full list of side effects and restriction of Qinlock, see the package leaflet.
Question
How is Qinlock used?
Answer
Qinlock is available as tablets to be taken by mouth and can only be obtained with a prescription. Treatment should be started by a doctor experienced in the treatment of cancer.
The recommended dose is 150 mg per day, taken at the same time each day. Treatment may be paused or the dose reduced to 100 mg per day if side effects are not tolerable. Treatment should continue as long as the patient benefits from it, or the side effects become unmanageable.
For more information about using Qinlock, see the package leaflet or contact your doctor or pharmacist.
Question
How does Qinlock work?
Answer
The active substance in Qinlock, ripretinib, is one of a group of cancer medicines called receptor tyrosine kinase inhibitors. It works by blocking the activity of receptors (targets) called KIT and PDGFRA on the surface of cancer cells. These receptors help to control cell growth but can be abnormal (mutated) in GIST cancer cells, causing the cells to multiply uncontrollably. By blocking the action of the abnormal receptors, the medicine is expected to help to slow down the tumour growth.
Question
What benefits of Qinlock have been shown in studies?
Answer
Qinlock was shown to be effective at treating GIST in a study involving 129 patients who had been previously treated with, or could not tolerate, at least three other cancer medicines. The study showed that patients treated with Qinlock lived on average for 27.6 weeks without their disease getting worse, compared with 4.1 weeks for patients given placebo (a dummy treatment).
Question
What measures are being taken to ensure the safe and effective use of Qinlock?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qinlock have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Qinlock are continuously monitored. Suspected side effects reported with Qinlock are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Qinlock
Answer
Qinlock received a marketing authorisation valid throughout the EU on 18 November 2021.