Rozlytrek
Authorised
This medicine is authorised for use in the European Union
entrectinib
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Rozlytrek is a cancer medicine. It can be used for treating patients from 1 month of age with solid tumours (cancer growths) that have a genetic abnormality called NTRK gene fusion. Rozlytrek is for use in patients with tumours that have spread nearby or to other parts of the body (metastatic cancer) or when removing the tumour by surgery could cause severe harm. It should be used only if the patient has not been treated previously with a medicine that works in the same way as Rozlytrek and other treatments are not suitable.
Rozlytrek can also be used for treating adults with advanced non-small-cell lung cancer that has a genetic abnormality called ROS1 gene fusion. It should be used only if the patient has not been treated previously with a medicine that blocks ROS1.
Rozlytrek contains the active substance entrectinib.
Rozlytrek can only be obtained with a prescription and treatment should be started by a doctor who is experienced in the use of cancer medicines.
Rozlytrek is available as capsules and granules taken once daily. Treatment should continue until the medicine stops working. The doctor may reduce the dose, interrupt treatment or stop it altogether if the patient has certain side effects.
For more information about using Rozlytrek, see the package leaflet or contact your doctor or pharmacist.
Cancers with NTRK gene fusion or ROS1 gene fusion produce abnormal proteins that cause an uncontrolled increase of cancer cells. Entrectinib, the active substance in Rozlytrek, blocks the action of these proteins and so prevents the increase in cancer cells. This slows down cancer growth.
Solid tumours with NTRK gene fusion
Ongoing studies involved a total of 74 adults with advanced solid tumours with NTRK gene fusion in whom previous treatment had stopped working or other treatment was not suitable. Patients received Rozlytrek until it stopped working or caused unacceptable side effects. Out of a total of 74 patients, the cancer shrank in 64% of patients and the average duration of response (period during which the cancer did not grow) was 12.9 months. Rozlytrek was not compared with another treatment for solid tumours.
Supporting studies indicate that the medicine is expected to work in the same way in patients from 12 years of age.
The effectiveness of Rozlytrek was investigated in two studies that involved a total of 44 children, 38 of whom were younger than 12 years of age. All patients had a solid tumour with NTRK gene fusion with no satisfactory treatment option available. Patients were followed for an average of 24 months. The analysis showed that about 73% of patients had a response to treatment (when the cancer shrinks or disappears), with 45% having a complete response, meaning that there was no sign of the cancer at the time of the analysis. Rozlytrek was not compared with another medicine.
Non-small-cell lung cancer with ROS1 gene fusion
Studies involved a total of 94 patients with advanced or metastatic non-small-cell lung cancer with ROS1 gene fusion. Patients were followed up for more than 12 months and they received Rozlytrek until it stopped working or caused unacceptable side effects. The cancer shrank in 73% of patients and the average duration of response was 16.5 months. The studies did not compare Rozlytrek with another treatment for non-small-cell lung cancer.
The most common side effects with Rozlytrek (which may affect more than 1 in 5 people) are tiredness, constipation, dysgeusia (taste disturbances), oedema (swelling with fluid retention), dizziness, diarrhoea, nausea (feeling sick), dysaesthesia (unpleasant and abnormal feeling when touched), dyspnoea (difficulty breathing), anaemia (low red blood cell count), increased weight, increased levels of creatinine in the blood (a possible sign of kidney problems), increased levels of liver enzymes (a possible sign of liver problems), pain, joint pain, cognitive disorders (problems with ability to think, learn and remember), vomiting, cough, and fever.
The most common serious side effects with Rozlytrek (which may affect more than 1 in 50 people) are lung infection, dyspnoea, cognitive impairment, fractures, fever and pleural effusion (build-up of fluid around the lungs).
For the full list of restrictions and side effects of Rozlytrek, see the package leaflet.
The European Medicines Agency considered that in patients with solid tumours with NTRK gene fusion, treatment with Rozlytrek is of benefit when other treatment is not available or does not work. Although data in children are limited, the effect seen in children is consistent with that seen in adolescents and adults. More information is needed on the medicine's effect on tumours in different sites and when other gene abnormalities are present. For non-small-cell lung cancer with ROS1 gene fusion, results currently available suggest that treatment with Rozlytrek can reduce the size of tumours. At the time of approval, there were very limited treatment options for patients with these types of cancer. The side effects of Rozlytrek are considered manageable.
Therefore, the Agency decided that Rozlytrek’s benefits are greater than its risks and it can be authorised for use in the EU. Rozlytrek has been given ‘conditional authorisation’. This means that it has been authorised on the basis of less comprehensive data than are normally required because it fulfils an unmet medical need. The Agency considers that the benefit of having the medicine available earlier outweighs any risks associated with using it while waiting for further evidence.
The company must provide further data on Rozlytrek. It must submit the results from ongoing studies on the effectiveness and safety of Rozlytrek in adults and children who have solid tumours with NTRK gene fusion. Every year, the Agency will review any new information that becomes available.
Since Rozlytrek has been given conditional authorisation, the company that markets Rozlytrek will provide further data from ongoing studies on the effectiveness and safety of Rozlytrek in adults and children who have solid tumours with NTRK gene fusion.
In addition to the data requested as part of the conditional marketing authorisation, the company that markets Rozlytrek will provide results from a study comparing the effectiveness of Rozlytrek with crizotinib (another cancer medicine) in patients with non-small-cell lung cancer with ROS1 fusion whose disease has spread to the brain.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rozlytrek have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Rozlytrek are continuously monitored. Side effects reported with Rozlytrek are carefully evaluated and any necessary action taken to protect patients.
Rozlytrek received a conditional marketing authorisation valid throughout the EU on 31 July 2020
Product information
Latest procedure affecting product information:
PSUSA/00010874/202406
24/03/2025
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
- Rozlytrek
- Active substance
- Entrectinib
- International non-proprietary name (INN) or common name
- entrectinib
- Therapeutic area (MeSH)
- Cancer
- Carcinoma, Non-Small-Cell Lung
- Anatomical therapeutic chemical (ATC) code
- L01EX14
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion,
- who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and
- who have not received a prior NTRK inhibitor
- who have no satisfactory treatment options.
Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
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