Vitrakvi (larotrectinib)

Numéro de dossier de l’APP: 21598

État des négociations:

Négociation conclue par une lettre d’intention

Indication(s):

For the treatment of adult and pediatric patients with solid tumours that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity, and; have no satisfactory treatment options.

Promoteur/fabricant:

Bayer Inc.

Numéro de projet de l’ACMTS:

PC0221

Lettre-contrat de l’APP:

2022-03-31

Conclusion du processus de négociation:

2022-11-07