Indications for entrectinib:
1. For the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) confirmed by an FDA-approved assay.
2. For the treatment of solid tumors in children older than 1 month and adult patients with the following characteristics:
(1) Confirmed neurotrophic tyrosine receptor kinase (NTRK) gene fusion by an FDA-approved assay, and without known acquired resistance mutations.
(2) Metastatic tumor, or surgical resection that could lead to serious complications.
(3) Disease progression following treatment, or the absence of satisfactory alternative treatment options.
(4) This indication was approved through an accelerated approval process based on tumor response rate and duration of response; continued approval may depend on validation and description of clinical benefit in confirmatory trials.
