BRIEF—Conditional UK approval for Merck KGaA's Tepmetko in NSCLC patients with MET exon 14 skipping

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a conditional Marketing Authorization (CMA) for Tepmetko (tepotinib) for advanced non-small cell lung cancer (NSCLC) patients with mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.

Merck KGaA’s drug is the first MHRA-authorized MET inhibitor in this condition. METex14 alterations occur in approximately 3%-4% of NSCLC cases and generally exhibit a poorer clinical prognosis compared with other types of NSCLC.

The authorization was conducted through Project ORBIS, a scheme coordinated by the US Food and Drug Administration, which reviews and approves promising cancer treatments concurrently with regulatory authorities in six other countries, including the UK’s MHRA.

This project aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies across the globe.