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 NHS 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.
