Overview

Rozlytrek is a cancer medicine. It can be used for treating patients from 12 years 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. It is available as capsules.

The recommended dose of Rozlytrek for adults is 600 mg once daily. The dose for children is based on the child’s height and weight. Treatment with Rozlytrek is continued until it 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 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, thereby slowing 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 size of the cancer was under control) 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.

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 blood creatinine (possible sign of kidney problems), 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 disorders 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. However, more information is needed on the medicine's effect on tumours in different sites and also 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. 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 there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

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.

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

Rozlytrek : EPAR - Overview

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Rozlytrek: EPAR - Risk-management-plan summary

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Product information

Rozlytrek: EPAR - Product information

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Latest procedure affecting product information: R/0015

07/07/2023

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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).

Rozlytrek: EPAR - All authorised presentations

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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 agents

Therapeutic 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.

Authorisation details

EMA product number
EMEA/H/C/004936

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Marketing authorisation holder
Roche Registration GmbH 

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Opinion adopted
28/05/2020
Marketing authorisation issued
31/07/2020
Revision
7

Assessment history

Rozlytrek: EPAR - Procedural steps taken and scientific information after the authorisation

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Rozlytrek: EPAR - Public assessment report

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CHMP summary of positive opinion for Rozlytrek

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Topics

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