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New potentially life-extending lung cancer drug which targets a specific genetic mutation recommended by NICE.

An innovative and potentially life-extending drug for treating people with a specific gene mutation of advanced non-small-cell lung cancer (NSCLC) has been recommended by NICE and will be available to patients from today (Thursday, 14 April).

The drug has been recommended for routine use across the NHS in England through Project Orbis, a programme to review and approve promising cancer drugs helping patients access treatments faster.

NICE has published its final appraisal document recommending tepotinib (also known as Tepmetko and produced by company Merck Serono Ltd) as an option for treating advanced NSCLC with METex14 skipping gene alterations in adults.

People with METex14 skipping alterations of NSCLC make up between 1-2% of all adults with lung cancer in England.

Those with METex14 skipping NSCLC are currently offered the same standard care as people with NSCLC without this specific biomarker, with treatments including chemotherapy, immunotherapy, and combinations of the two, known as chemo-immunotherapy. People with METex14 skipping NSCLC currently have a poorer prognosis than people without the biomarker.

Tepotinib, which requires people to take two tablets once daily, provides a new targeted treatment for adults with METex14 skipping gene alterations. Just over 700 people in England would be eligible to receive tepotinib as either a first or second-line treatment.

Clinical trial evidence, which included examining previous trial data and analysing real-world data, shows that although there is limited data, tepotinib may extend life.

Tepotinib is likely be offered as a first-line treatment for people with METex14 skipping NSCLC, once it has been confirmed by genomic testing. Medical practitioners would continue to use other first-line treatment options until the mutation had been confirmed.

Helen Knight, interim director for medicines evaluation at NICE, said:

“For the first time, people with advanced stage non-small-cell lung cancer (NSCLC) could be able to access a treatment which specifically targets the METex14 skipping mutation.

“This treatment has the potential to extend people’s lives and allows patients to take tablets rather than undergoing chemotherapy and chemo-immunotherapy, which requires them to spend a day in a hospital or other medical practice.

“The option to use genetic testing to help diagnose whether a person has the METex14 skipping mutation, and then tailoring their treatment accordingly, is a significant development and we will continue to work with our partners to ensure innovative treatments which benefit people are made available as soon as possible.”

A confidential price discount has been agreed between NHS England and Improvement and the company, through a commercial agreement ensuring the treatment is available to patients from today.

Professor Dame Sue Hill, Chief Scientific Officer and Senior Responsible Officer for Genomics in the NHS, says:

“The approval of this new treatment is fantastic news and to ensure patients receive it, the genomic test for this particular type of lung cancer will be added it to the National Genomic Test Directory.

“This means patients carrying the gene mutation can benefit from the most effective treatments and it’s a great example of how the NHS Genomic Medicine Service is harnessing the power of genomics to deliver precision medicine straight to patients.”

Further details on the final appraisal document on tepotinib for treating advanced non-small-cell lung cancer with MET gene alterations can be found here.