Tepmetko

The medicine can only be obtained with a prescription, and treatment should be started and supervised by a doctor who is experienced in using cancer medicines.

The patient’s cancer should be tested before starting treatment to confirm METex14 skipping mutations.

Tepmetko is available as tablets and is taken by mouth. The recommended dose is 450 mg once per day. Treatment can continue until the patient no longer benefits from it. If certain side effects develop, the doctor may decide to reduce the dose to 225 mg once per day, or to interrupt or stop treatment with Tepmetko.

For more information about using Tepmetko, see the package leaflet or contact your doctor or pharmacist.

The MET protein belongs to a family of enzymes called receptor tyrosine kinases, which are involved in the growth of cells. In NSCLC patients with ‘METex14 skipping’, an abnormal form of the MET protein is produced that causes cancer cells to divide and grow in an uncontrolled fashion. The active substance in Tepmetko, tepotinib, is a receptor tyrosine kinase inhibitor that attaches to this abnormal MET protein inside cancer cells. This stops the effect of MET, helping to slow down the growth and spread of the cancer.

In one main study involving 138 patients, Tepmetko was effective in treating adults with NSCLC with METex14 skipping mutations whose disease had progressed after previously being treated with other cancer medicines. Tepmetko was not compared with any other treatment or placebo (dummy treatment).

Response to treatment (shrinkage in the size of the cancer) was assessed using body scans. Around 44% (61 out of 138) of the patients showed partial or complete cancer shrinkage after treatment with Tepmetko. On average, responses lasted for over 11 months.

The most common side effects with Tepmetko (which may affect more than 1 in 5 people) are oedema (build-up of fluid), nausea (feeling sick), low albumin level in the blood, diarrhoea, and increase in creatinine level in the blood (a sign of kidney problems). The most common serious side effects with Tepmetko (which may affect more than 1 in 100 people) are peripheral oedema (swelling especially of the ankles and feet), generalised oedema (build-up of fluid in the whole body) and interstitial lung disease (disorder causing scarring in the lungs).

For the full list of side effects and restrictions of Tepmetko, see the package leaflet.

There are currently no specific treatment options for patients with advanced NSCLC with METex14 skipping mutations. Although the main study did not compare Tepmetko with another cancer treatment, it showed that the medicine was effective in patients whose cancer had progressed after several different treatments. In general, Tepmetko’s side effects were considered manageable.

The European Medicines Agency therefore decided that Tepmetko’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 Tepmetko have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Tepmetko are continuously monitored. Suspected side effects reported with Tepmetko are carefully evaluated and any necessary action taken to protect patients.

Tepmetko received a marketing authorisation valid throughout the EU on 16 February 2022.