News
MHRA (UK) approves Tepmetko to treatMETex14 skipping mutated NSCLC.
The MHRA (UK) has granted a Marketing Authorisation for Merck’s Tepmetko (tepotinib), an oral treatment for advanced non-small cell lung cancer (NSCLC) with METex14 skipping - a targetable gene alteration found in NSCLC.
Tepotinib is the first oral MET inhibitor to receive Marketing Authorisation from the MHRA for advanced non-small cell lung cancer (NSCLC).
This authorisation was conducted through the FDA-coordinated Project ORBIS, which reviews and approves promising cancer treatments concurrently with regulatory authorities in six other countries, including the UK’s MHRA. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies across the globe.
MHRA’s authorisation is based on results from the Phase II VISION study evaluating tepotinib as a monotherapy for patients with advanced or metastatic NSCLC with METex14 skipping alterations.
Condition: NSCLC / MET
Type: drug