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NICE turns down Bayer's tumour-agnostic therapy Vitrakvi over evidence concerns

Published on 20/01/20 at 10:17am

UK drug watchdog NICE has turned down Bayer’s Vitrakvi (larotrectinib) as a tumour-agnostic treatment solution on the NHS after it could not consider it a cost-effective use of the health service’s limited resources due to a lack of evidence.

The therapy was being considered in the treatment of advanced neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in adults and children who have no satisfactory treatment options.

In the same announcement, NICE revealed that Roche’s Rozlytrek (entrectinib) could instead become the first histology-independent cancer drug to be recommended for NHS use, should it secure marketing authorisation in Europe.

Where conventional cancer drugs are indicated for treatment depending on the location of the primary tumour within the body, tumour-agnostic therapies focus on a cancer’s genetic and molecular characteristics.

In clinical studies, Vitrakvi caused shrinkage in tumours with NTRK gene fusions, but data comparing this efficacy to other therapies was not provided. NTRK gene fusions are thought to be a driver of tumour growth and are present in less than 1% of common tumours, though they are much more prevalent in rare cancers. Between 600 and 700 patients in the UK are thought to be affected, with no satisfactory treatment currently available.

Matt Fellows

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