The drug is claimed to be the first and only oral MET inhibitor recommended to treat advanced NSCLC harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations for use on the NHS in England, Northern Ireland, and Wales.
Through Project Orbis, tepotinib has been recommended for routine use across the NHS in England.
The NICE appraisal has been supported by the Phase II VISION study, which is assessing tepotinib as a monotherapy to treat advanced or metastatic NSCLC with METex14 skipping alterations.
The drug showed significant benefits for advanced NSCLC with METex14 skipping patients who were enrolled by liquid biopsy or tissue biopsy in the study.
Furthermore, the VISION study demonstrated an objective response rate, by independent review of 49.1%.
Merck general manager Doina Ionescu said: “We are committed to our vision for the future of medicine – moving away from a ‘one size fits all’ approach that is now the norm for many diseases to a focus on personalised medicines and the development of innovative targeted treatments, like tepotinib.
“As the first therapy of its kind to be recommended by NICE, tepotinib has shown to help slow disease progression and prolong survival in patients with this gene mutation.
“Importantly, the NHS is also making progress in the screening of lung cancer patients with these types of specific gene mutations, helping to identify those patients who are most likely to benefit from this treatment.”
In February last year, tepotinib was approved to treat metastatic NSCLC with METex14 skipping alterations in adult patients in the US.
The drug was also approved as a monotherapy by the European Commission for the same indication in February this year.
Currently, tepotinib is under review by the Scottish Medicines Consortium (SMC) in Scotland and is expected to receive approval in the second quarter of this year.