Human medicines European public assessment report (EPAR): Tepmetko, tepotinib, Date of authorisation: 16/02/2022, Revision: 4, Status: Authorised

Tepmetko RSS Authorised This medicine is authorised for use in the European Union tepotinib Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Tepmetko is a cancer medicine that is used to treat adults with non-small cell lung cancer (NSCLC) when the cancer is advanced and its cells have particular genetic mutations (changes) leading to ‘mesenchymal-epithelial transition factor gene exon 14’ (METex14) skipping. This means that the cancer cells make an abnormal form of a protein called MET because a part of the MET gene known as exon 14 is not used. Tepmetko is used when the patient needs further treatment after receiving immunotherapy or platinum-based chemotherapy, or both. Tepmetko contains the active substance tepotinib. Expand section Collapse section How is Tepmetko used? 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. How does Tepmetko work? 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. What benefits of Tepmetko have been shown in studies? 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. What are the risks associated with Tepmetko? 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. Why is Tepmetko authorised in the EU? 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. What measures are being taken to ensure the safe and effective use of Tepmetko? 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. Other information about Tepmetko Tepmetko received a marketing authorisation valid throughout the EU on 16 February 2022. Tepmetko : EPAR - Medicine overview Reference Number: EMA/778167/2021 English (EN) (119.86 KB - PDF) First published: 05/05/2022 View Other languages (22) български (BG) (157.42 KB - PDF) First published: 05/05/2022 View español (ES) (140.68 KB - PDF) First published: 05/05/2022 View čeština (CS) (154.68 KB - PDF) First published: 05/05/2022 View dansk (DA) (130.87 KB - PDF) First published: 05/05/2022 View Deutsch (DE) (153.86 KB - PDF) First published: 05/05/2022 View eesti keel (ET) (136.95 KB - PDF) First published: 05/05/2022 View ελληνικά (EL) (173.75 KB - PDF) First published: 05/05/2022 View français (FR) (133.36 KB - PDF) First published: 05/05/2022 View hrvatski (HR) (162.24 KB - PDF) First published: 05/05/2022 View italiano (IT) (131.26 KB - PDF) First published: 05/05/2022 View latviešu valoda (LV) (160.21 KB - PDF) First published: 05/05/2022 View lietuvių kalba (LT) (154.59 KB - PDF) First published: 05/05/2022 View magyar (HU) (153.88 KB - PDF) First published: 05/05/2022 View Malti (MT) (155.4 KB - PDF) First published: 05/05/2022 View Nederlands (NL) (130.81 KB - PDF) First published: 05/05/2022 View polski (PL) (156.96 KB - PDF) First published: 05/05/2022 View português (PT) (133.26 KB - PDF) First published: 05/05/2022 View română (RO) (151.09 KB - PDF) First published: 05/05/2022 View slovenčina (SK) (153.84 KB - PDF) First published: 05/05/2022 View slovenščina (SL) (151.43 KB - PDF) First published: 05/05/2022 View Suomi (FI) (128.7 KB - PDF) First published: 05/05/2022 View svenska (SV) (129.2 KB - PDF) First published: 05/05/2022 View Tepmetko : EPAR - Risk-management-plan summary English (EN) (160.31 KB - PDF) First published: 05/05/2022 View Product information Tepmetko : EPAR - Product information English (EN) (357.19 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View Other languages (24) български (BG) (832.19 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View español (ES) (751.47 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View čeština (CS) (932.13 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View dansk (DA) (338.29 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View Deutsch (DE) (786.46 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View eesti keel (ET) (728.3 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View ελληνικά (EL) (779.89 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View français (FR) (867.22 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View hrvatski (HR) (829.72 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View íslenska (IS) (672.48 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View italiano (IT) (798.02 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View latviešu valoda (LV) (393.7 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View lietuvių kalba (LT) (821.68 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View magyar (HU) (866.64 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View Malti (MT) (1.03 MB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View Nederlands (NL) (752.57 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View norsk (NO) (726.8 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View polski (PL) (914.36 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View português (PT) (737.95 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View română (RO) (802.24 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View slovenčina (SK) (921 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View slovenščina (SL) (808.83 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View Suomi (FI) (807.36 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View svenska (SV) (739.13 KB - PDF) First published: 05/05/2022 Last updated: 17/04/2026 View Latest procedure affecting product information: VR/0000337926 17/04/2026 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). Tepmetko : EPAR - All authorised presentations English (EN) (8.61 KB - PDF) First published: 05/05/2022 View Other languages (24) български (BG) (31.3 KB - PDF) First published: 05/05/2022 View español (ES) (9.53 KB - PDF) First published: 05/05/2022 View čeština (CS) (18.61 KB - PDF) First published: 05/05/2022 View dansk (DA) (13.41 KB - PDF) First published: 05/05/2022 View Deutsch (DE) (9.37 KB - PDF) First published: 05/05/2022 View eesti keel (ET) (9.44 KB - PDF) First published: 05/05/2022 View ελληνικά (EL) (30.87 KB - PDF) First published: 05/05/2022 View français (FR) (9.35 KB - PDF) First published: 05/05/2022 View hrvatski (HR) (20.25 KB - PDF) First published: 05/05/2022 View íslenska (IS) (13.34 KB - PDF) First published: 05/05/2022 View italiano (IT) (9.59 KB - PDF) First published: 05/05/2022 View latviešu valoda (LV) (29.86 KB - PDF) First published: 05/05/2022 View lietuvių kalba (LT) (30.25 KB - PDF) First published: 05/05/2022 View magyar (HU) (17.17 KB - PDF) First published: 05/05/2022 View Malti (MT) (25.46 KB - PDF) First published: 05/05/2022 View Nederlands (NL) (9.36 KB - PDF) First published: 05/05/2022 View norsk (NO) (9.39 KB - PDF) First published: 05/05/2022 View polski (PL) (19.1 KB - PDF) First published: 05/05/2022 View português (PT) (9.42 KB - PDF) First published: 05/05/2022 View română (RO) (28.15 KB - PDF) First published: 05/05/2022 View slovenčina (SK) (18.74 KB - PDF) First published: 05/05/2022 View slovenščina (SL) (17.77 KB - PDF) First published: 05/05/2022 View Suomi (FI) (9.58 KB - PDF) First published: 05/05/2022 View svenska (SV) (9.31 KB - PDF) First published: 05/05/2022 View Product details Name of medicine Tepmetko Active substance tepotinib hydrochloride monohydrate International non-proprietary name (INN) or common name tepotinib Therapeutic area (MeSH) Carcinoma, Non-Small-Cell Lung Anatomical therapeutic chemical (ATC) code L01EX21 Pharmacotherapeutic group Antineoplastic agents Therapeutic indication Tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. Authorisation details EMA product number EMEA/H/C/005524 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 . Marketing authorisation holder Merck Europe B.V. Gustav Mahlerplein 102 1082 MA Amsterdam The Netherlands Opinion adopted 16/12/2021 Marketing authorisation issued 16/02/2022 Revision 4 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Tepmetko: EPAR - Procedural steps taken and scientific information after authorisation English (EN) (147.04 KB - PDF) First published: 21/07/2023 Last updated: 17/04/2026 View Initial marketing authorisation documents Tepmetko : EPAR - Public assessment report Adopted Reference Number: EMA/36625/2022 English (EN) (4.38 MB - PDF) First published: 05/05/2022 View CHMP summary of positive opinion for Tepmetko Adopted English (EN) (92.92 KB - PDF) First published: 17/12/2021 View This page was last updated on 17/04/2026 Share this page