Rozlytrek

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.

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

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.

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.