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Rozlytrek (entrectinib) – New orphan drug approval

August 15, 2019 - The FDA announced the approval of Roche and Genentech’s Rozlytrek (entrectinib), for the treatment of: (1) adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive; and (2) 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.

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