Larotrectinib has failed to secure NICE approval for treating advanced neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in adults and children who have no satisfactory treatment options.
To support the application for approval, the company presented a pooled analysis of 102 patients from three trials:
NAVIGATE is an ongoing trial for patients ≥12 years with locally advanced or metastatic NTRK fusion-positive tumours who have had prior therapy or who would be unlikely to derive clinical benefit from standard care.
SCOUT is an ongoing trial for children with locally advanced or metastatic solid tumours or primary central nervous system (CNS) tumours.
LOXO-TRK-14001 was a dose-finding study in patients with solid tumours with NTRK gene fusions.
However, in draft guidance, NICE concludes that the key clinical evidence presented is not generalisable to NHS clinical practice because of the over-representation of high NTRK-prevalent tumour types and distribution of tumour types, and the unknown effect of patient characteristics.
The draft decision is open for public comment. The closing date for receipt of comments is Friday, 7 February 2020.
The final decision is expected to be published in May.