Therapeutic Response

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

Statements

Source and description
Rozlytrek (entrectinib) [product monograph]. HC. Health Canada approved entrectinib for the treatment of adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with 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.