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ROS1-Positive Non-Small Cell Lung Cancer: ROZLYTREK is indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC).
NTRK Gene Fusion-Positive Solid Tumors: ROZLYTREK is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have either progressed following treatment or have no satisfactory alternative therapy.
This indication is approved based on tumor response rate and durability of response [see Pharmacology: Pharmacodynamics: Clinical Studies: NTRK Gene Fusion-Positive Solid Tumors under Actions].
