Qinlock
Authorised
This medicine is authorised for use in the European Union
ripretinib
MedicineHumanAuthorised
Overview
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.
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.
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.
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).
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.
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.
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.
Qinlock received a marketing authorisation valid throughout the EU on 18 November 2021.
Product information
Latest procedure affecting product information: IB/0012
21/06/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Qinlock
- Active substance
- ripretinib
- International non-proprietary name (INN) or common name
- ripretinib
- Therapeutic area (MeSH)
- Gastrointestinal Stromal Tumors
- Anatomical therapeutic chemical (ATC) code
- L01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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.
News on Qinlock
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