Therapeutic Response

v::NTRK1 status confers therapeutic sensitivity to Entrectinib in patients with Any solid tumor.

Statements

Source and description
Rozlytrek (entrectinib) [product information]. EMA. 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.
Rozlytrek (entrectinib) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to entrectinib for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, (ii) are metastatic or where surgical resection is likely to result in severe morbidity, and (iii) have progressed following treatment or have no satisfactory alternative therapy. Entrectinib's package insert further states that this indication is approved under accelerated approval based on tumor response rate and durability of response. Furthermore, continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.