Favourable opinion for reimbursement only in “VITRAKVI as monotherapy is indicated for the treatment of adult patients with:
soft tissue sarcoma,
salivary gland cancer,
non-medullary thyroid cancer,
that displays a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.
Unfavourable opinion for reimbursement in the other situations covered by the MA indication in adults.
This opinion does not modify the Transparency Committee’s conclusions concerning the indications in children, cf. Transparency Committee opinion of 8 March 2023 without any new data supplied.
Clinical Benefit
Low
The Committee deems that the clinical benefit of VITRAKVI (larotrectinib) is low only for the treatment of adult patients with:
soft tissue sarcoma,
salivary gland cancer,
non-medullary thyroid cancer,
that displays a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.
Insufficient
The Committee deems that the clinical benefit of VITRAKVI (larotrectinib) is insufficient to justify public funding in the other MA situations in adults.
Clinical Added Value
no clinical added value
Considering:
data suggesting an objective response rate of more than 50% (variable depending on tumour location) in patients treated with VITRAKVI (larotrectinib) in the non-comparative phase 2 NAVIGATE study;
the medical need considered to be unmet in the situations where no treatment options are available apart from supportive care, following the failure of standard treatments appropriate to the tumour location or when surgery is likely to result in severe morbidity;
and despite:
the heterogeneity of the clinical situations covered by the indication, in particular in terms of prognosis, treatment strategy and histology;
the results for an interim endpoint (partial or complete objective response rate) with no evidence of a correlation with a clinical benefit in terms of overall survival;
the absence of robust comparative data enabling a formal conclusion to be reached with respect to the clinical benefit of VITRAKVI (larotrectinib) compared to supportive care;
the lack of evidence of an additional benefit in terms of quality of life;
the Committee deems that VITRAKVI (larotrectinib) 25 mg, 100 mg and 20 mg/mL provides no clinical added value (CAV V) compared to the current care pathway for soft tissue sarcoma, salivary gland cancer and non-medullary thyroid cancer, with NTRK gene fusion.
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