Based on these results the panel added larotrectinib and entrectinib as subsequent treatment options for patients with NTRK gene fusion-positive disease, acknowledging that these therapies will not be appropriate for most patients due to the rarity of the NTRK fusion in CRC.

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)...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.

In total, 20 pts with ROS1-fp NSCLC and 10 pts with NTRK-fp solid tumours (5 salivary, 1 breast, 1 colorectal, 1 NSCLC, 1 sarcoma, 1 thyroid) were efficacy evaluable. For both cohorts, median survival follow-up was 38.6 mos and ORR was 70%....The 24-mos OS rates were 65% (ROS1-fp NSCLC) and 90% (NTRK-fp solid tumours). In pts without baseline CNS mets by investigator, ORR was 76% (ROS1-fp NSCLC; n=13/17) and 75% (NTRK-fp solid tumours; n=6/8). In pts with baseline CNS mets by BICR (3 ROS1-fp; 1 NTRK-fp), one pt (NTRK-fp) had an IC response....Entrectinib showed deep and durable responses and manageable safety in Japanese pts with locally advanced/metastatic ROS1-fp NSCLC or NTRK-fp solid tumours.