Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that v::NTRK2 status confers therapeutic sensitivity to Entrectinib in patients with Any solid tumor.
The European Medicines Agency (EMA) has conditionally authorized entrectinib for the treatment of adult and pediatric patients 12 years of age and older with solid tumors expressing a neuotrophic 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 not received a prior NTRK inhibitor, and who have no satisfactory treatment options.
This statement is based on a regulatory approval from the European Medicines Agency:
Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients older than one month with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion (i) who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and (ii) who have not received a prior NTRK inhibitor, (iii) who have no satisfactory treatment options.