ROZLYTREK is a kinase inhibitor indicated for the treatment of...Adult and pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation.

The cohort of patients with NTRK-fp gastrointestinal cancers comprised 12 adults (1 cholangiocarcinoma; 7 colorectal carcinomas; 3 pancreatic cancers; 1 other) aged 31–75 (median 59.5) years; half of them were male and 75% were white. Eight (66.7%) patients reported one (n=2), two (n=4) or three (n=2) prior lines of therapy....Median (95% CI) DoR, PFS, and OS were: 12.9 (7.1–15.1), 7.1 (2.4–16.0), and 16.0 (11.2–NE) months, respectively. The integrated safety population comprised of 504 patients who received ≥1 dose of entrectinib....entrectinib continues to demonstrate a high level of clinical benefit for patients with NTRK-fp solid tumors, and a manageable safety profile, including patients with a variety of gastrointestinal cancers.