Following a resubmission from manufacturer Merck, the Scottish Medicines Consortium (SMC) has now approved Tepmetko (tepotinib) for use on the NHS in Scotland.
It is recommended for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.
This change was made following an initial decision by the SMC in June 2022 not to recommend tepotinib. There is now equal access to tepotinib across Great Britain, following the positive recommendation by the National Institute for Health and Care Excellence (NICE) on 14 April 2022.
In Northern Ireland tepotinib is available in line with the European Medicines Agency marketing authorisation 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.
Dr Brian Clark, Consultant Clinical Oncologist, Beatson West of Scotland Cancer Centre, explained: “Treatment options are limited for advanced NSCLC patients with METex14 skipping alterations and survival for this rare subtype of cancer remains poor in Scotland.
“As the first targeted therapy available in Scotland for this group of patients, tepotinib is changing the way we treat these aggressive types of cancers and we will hopefully start to see improvements in patient outcomes. Key to this will be the uptake of biomarker testing now that we have routine access on the NHS.”
METex14 skipping alterations have been recognised as a therapeutic target and can be identified via a tissue sample or liquid biopsy.
To enable advanced genomic testing, the Scottish Genetics Laboratory Consortium works across four regional genetics centres in Aberdeen, Dundee, Edinburgh and Glasgow, which are equipped with novel technology to manage more complex tests that cannot be completed at other local laboratory sites.
Data from the Phase II VISION study has demonstrated an objective response rate of 50.8% in the combined-biopsy group. The median progression-free survival was 11.2 months, and the median overall survival was 19.3 months.