EMA Recommends Granting a Marketing Authorisation for Tepotinib

On 16 December 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product tepotinib (Tepmetko), intended for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping.

The applicant for this medicinal product is Merck Europe B.V.

Tepmetko will be available as 225 mg film-coated tablets. The active substance of Tepmetko is tepotinib, a MET inhibitor (ATC code: L01EX21) which blocks MET phosphorylation and MET-dependent downstream signalling.

The benefits of Tepmetko are its objective response rate and response duration in patients with NSCLC harbouring alterations leading to METex14 skipping.

The most common side effects are oedema (mainly peripheral oedema), nausea, hypoalbuminaemia, and diarrhoea.

The full indication is:

Tepmetko as monotherapy is indicated for the treatment of adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Tepmetko should be prescribed by physicians experienced in the use of anticancer medicinal products.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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